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FREMONT, Calif., May 09, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a CNS-focused company with a lead product, M207, that recently established a differentiated safety and efficacy profile in a pivotal trial as an acute treatment for migraine, today reported financial results for the first quarter ended March 31, 2017. In addition, John P. Walker, Chairman of the company’s Board of Directors, has been named Interim Chief Executive Officer to replace Konstantinos Alataris who has resigned as CEO and director of the company. Georgia Erbez, our Chief Business Officer and Interim Chief Financial Officer, has assumed full responsibility for both functions. “The first quarter saw our lead product candidate meet both co-primary endpoints in ZOTRIP, our pivotal efficacy study of M207 as an acute treatment for migraine. In addition, the company completed a follow-on offering that resulted in $29.3 million in gross proceeds earmarked for advancing M207 towards FDA approval. These two important accomplishments are a result of the commitment and capabilities of Zosano’s management team and gives me great confidence in our ability to continue to meet the strategic milestones established by the company.” “The pivotal study results importantly validate our technology platform, and, if approved by the FDA, point to M207’s positioning as an acute treatment for migraine sufferers that is differentiated from what is currently available.  I look forward to working with the team at Zosano and to bringing this exciting new drug to market,” commented John P. Walker, Interim Chief Executive Officer. "On behalf of the Board of Directors, I want to thank Konstantinos Alataris for his efforts and commitment to the company over the past two years. We wish him well in his future endeavors,” added Walker. In February, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. The 3.8mg dose achieved a p value of <0.05  in the secondary endpoints of pain freedom at 45 minutes and 1 hour, and showed durability of effect on pain freedom to 24 and 48 hours. These results demonstrated that M207 not only provided fast onset but also a durability of effect, up to 2 days and hence freedom from recurrence of migraine. Additionally, M207 demonstrated a similar safety profile as other triptans and no Serious Adverse Events (SAEs) were reported in the trial. The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study of M207, will be sufficient to file for approval under a 505(b)(2) pathway. The Company plans to initiate the safety study in the second half of 2017. Financial Results for the First Quarter Ended March 31, 2017 Walker brings to Zosano more than 40 years of experience as a Board Chairman, Chief Executive Officer and interim CEO at life science companies. In these roles, he has been involved with Vitaphore, which was sold to Union Carbide Chemicals and Plastics; Arris/Axys, which was sold to Celera Genomics; Centaur, which was sold to Renovis; Signal Pharmaceuticals, which was sold to Celgene; Kai Pharmaceuticals, which was sold to Amgen; Guava Technologies, which was sold to Millipore; and iPierian, which was sold to Bristol Myers Squibb as well as in the mergers of Novacea and Transcept and of Renovis and Evotec. He is currently serving as Executive Chairman of Vizuri Life Sciences LLC and has been a director on the Boards of other life science companies, including Geron, Evotec and Affymax. In addition, he currently serves on the Board of Directors of the Lucille Packard Children’s Hospital at Stanford University and Random Acts of Flowers, a non-profit that repurposes flowers for ill patients. He began his early business career at American Hospital Supply Corporation where he became President of the Hospital Company. Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound.  According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to $4.4 billion in 2020. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits. M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.  In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society. Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.


FREMONT, Calif., May 09, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a CNS-focused company with a lead product, M207, that recently established a differentiated safety and efficacy profile in a pivotal trial as an acute treatment for migraine, today reported financial results for the first quarter ended March 31, 2017. In addition, John P. Walker, Chairman of the company’s Board of Directors, has been named Interim Chief Executive Officer to replace Konstantinos Alataris who has resigned as CEO and director of the company. Georgia Erbez, our Chief Business Officer and Interim Chief Financial Officer, has assumed full responsibility for both functions. “The first quarter saw our lead product candidate meet both co-primary endpoints in ZOTRIP, our pivotal efficacy study of M207 as an acute treatment for migraine. In addition, the company completed a follow-on offering that resulted in $29.3 million in gross proceeds earmarked for advancing M207 towards FDA approval. These two important accomplishments are a result of the commitment and capabilities of Zosano’s management team and gives me great confidence in our ability to continue to meet the strategic milestones established by the company.” “The pivotal study results importantly validate our technology platform, and, if approved by the FDA, point to M207’s positioning as an acute treatment for migraine sufferers that is differentiated from what is currently available.  I look forward to working with the team at Zosano and to bringing this exciting new drug to market,” commented John P. Walker, Interim Chief Executive Officer. "On behalf of the Board of Directors, I want to thank Konstantinos Alataris for his efforts and commitment to the company over the past two years. We wish him well in his future endeavors,” added Walker. In February, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. The 3.8mg dose achieved a p value of <0.05  in the secondary endpoints of pain freedom at 45 minutes and 1 hour, and showed durability of effect on pain freedom to 24 and 48 hours. These results demonstrated that M207 not only provided fast onset but also a durability of effect, up to 2 days and hence freedom from recurrence of migraine. Additionally, M207 demonstrated a similar safety profile as other triptans and no Serious Adverse Events (SAEs) were reported in the trial. The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study of M207, will be sufficient to file for approval under a 505(b)(2) pathway. The Company plans to initiate the safety study in the second half of 2017. Financial Results for the First Quarter Ended March 31, 2017 Walker brings to Zosano more than 40 years of experience as a Board Chairman, Chief Executive Officer and interim CEO at life science companies. In these roles, he has been involved with Vitaphore, which was sold to Union Carbide Chemicals and Plastics; Arris/Axys, which was sold to Celera Genomics; Centaur, which was sold to Renovis; Signal Pharmaceuticals, which was sold to Celgene; Kai Pharmaceuticals, which was sold to Amgen; Guava Technologies, which was sold to Millipore; and iPierian, which was sold to Bristol Myers Squibb as well as in the mergers of Novacea and Transcept and of Renovis and Evotec. He is currently serving as Executive Chairman of Vizuri Life Sciences LLC and has been a director on the Boards of other life science companies, including Geron, Evotec and Affymax. In addition, he currently serves on the Board of Directors of the Lucille Packard Children’s Hospital at Stanford University and Random Acts of Flowers, a non-profit that repurposes flowers for ill patients. He began his early business career at American Hospital Supply Corporation where he became President of the Hospital Company. Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound.  According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to $4.4 billion in 2020. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits. M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.  In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society. Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.


FREMONT, Calif., May 09, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a CNS-focused company with a lead product, M207, that recently established a differentiated safety and efficacy profile in a pivotal trial as an acute treatment for migraine, today reported financial results for the first quarter ended March 31, 2017. In addition, John P. Walker, Chairman of the company’s Board of Directors, has been named Interim Chief Executive Officer to replace Konstantinos Alataris who has resigned as CEO and director of the company. Georgia Erbez, our Chief Business Officer and Interim Chief Financial Officer, has assumed full responsibility for both functions. “The first quarter saw our lead product candidate meet both co-primary endpoints in ZOTRIP, our pivotal efficacy study of M207 as an acute treatment for migraine. In addition, the company completed a follow-on offering that resulted in $29.3 million in gross proceeds earmarked for advancing M207 towards FDA approval. These two important accomplishments are a result of the commitment and capabilities of Zosano’s management team and gives me great confidence in our ability to continue to meet the strategic milestones established by the company.” “The pivotal study results importantly validate our technology platform, and, if approved by the FDA, point to M207’s positioning as an acute treatment for migraine sufferers that is differentiated from what is currently available.  I look forward to working with the team at Zosano and to bringing this exciting new drug to market,” commented John P. Walker, Interim Chief Executive Officer. "On behalf of the Board of Directors, I want to thank Konstantinos Alataris for his efforts and commitment to the company over the past two years. We wish him well in his future endeavors,” added Walker. In February, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. The 3.8mg dose achieved a p value of <0.05  in the secondary endpoints of pain freedom at 45 minutes and 1 hour, and showed durability of effect on pain freedom to 24 and 48 hours. These results demonstrated that M207 not only provided fast onset but also a durability of effect, up to 2 days and hence freedom from recurrence of migraine. Additionally, M207 demonstrated a similar safety profile as other triptans and no Serious Adverse Events (SAEs) were reported in the trial. The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study of M207, will be sufficient to file for approval under a 505(b)(2) pathway. The Company plans to initiate the safety study in the second half of 2017. Financial Results for the First Quarter Ended March 31, 2017 Walker brings to Zosano more than 40 years of experience as a Board Chairman, Chief Executive Officer and interim CEO at life science companies. In these roles, he has been involved with Vitaphore, which was sold to Union Carbide Chemicals and Plastics; Arris/Axys, which was sold to Celera Genomics; Centaur, which was sold to Renovis; Signal Pharmaceuticals, which was sold to Celgene; Kai Pharmaceuticals, which was sold to Amgen; Guava Technologies, which was sold to Millipore; and iPierian, which was sold to Bristol Myers Squibb as well as in the mergers of Novacea and Transcept and of Renovis and Evotec. He is currently serving as Executive Chairman of Vizuri Life Sciences LLC and has been a director on the Boards of other life science companies, including Geron, Evotec and Affymax. In addition, he currently serves on the Board of Directors of the Lucille Packard Children’s Hospital at Stanford University and Random Acts of Flowers, a non-profit that repurposes flowers for ill patients. He began his early business career at American Hospital Supply Corporation where he became President of the Hospital Company. Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound.  According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to $4.4 billion in 2020. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits. M207 is our proprietary formulation of zolmitriptan coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.  In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society. Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com. This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.


MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) will present four research posters on Latuda® (lurasidone HCl) and one on novel drug candidate dasotraline at the 170th Annual Meeting of the American Psychiatric Association (APA), which will be held May 20-24, 2017, in San Diego, California. LATUDA is an atypical antipsychotic agent approved in the U.S. for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in adults and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age). Dasotraline is a dopamine and norepinephrine reuptake inhibitor (DNRI) currently in development to evaluate its use in treating attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). “ At Sunovion, we maintain our unwavering commitment to innovation in psychiatry, driven by awareness of the significant medical needs that exist for individuals, their families and communities,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “ The data being presented on LATUDA and dasotraline are encouraging for patients and their families who are living with challenging psychiatric illnesses that may be difficult to treat.” Key data from multiple studies for LATUDA demonstrate meaningful clinical benefit and that the treatment was well tolerated in adults, children and adolescents (10 to 17 years of age) with bipolar depression and adolescents (13 to 17 years of age) with schizophrenia. New data presented for the first time on novel drug candidate dasotraline showed statistically significant and clinically meaningful reductions in the frequency and severity of binge eating and that dasotraline was generally well tolerated. LATUDA is approved in the U.S. for the treatment of: The efficacy of LATUDA was established in a 6-week monotherapy study and a 6-week adjunctive therapy study with lithium or valproate in adult patients with bipolar depression. The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies in adult patients and one 6-week placebo-controlled study in adolescents (13 to 17 years). The most common side effects associated with LATUDA include sleepiness or drowsiness; restlessness or feeling the need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea. LATUDA is available in five tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. Please see Important Safety Information, including Boxed Warnings, below and full Prescribing Information at www.LATUDA.com. INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression. LATUDA can cause serious side effects, including stroke that can lead to death, which can happen in elderly people with dementia who take medicines like LATUDA. Neuroleptic malignant syndrome (NMS) is a rare but very serious condition that can happen in people who take antipsychotic medicines, including LATUDA. NMS can cause death and must be treated in a hospital. Call your health care provider right away if you become severely ill and have some or all of these symptoms: high fever, excessive sweating, rigid muscles, confusion, or changes in your breathing, heartbeat or blood pressure. Tardive dyskinesia (TD) is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA. Increases in blood sugar can happen in some people who take LATUDA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your health care provider should check your blood sugar before you start LATUDA and during therapy. Call your health care provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity. Increases in triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA. You may not have any symptoms, so your health care provider may decide to check your cholesterol and triglycerides during your treatment with LATUDA. Some patients may gain weight while taking LATUDA. Your doctor should check your weight regularly. Tell your doctor if you experience any of these: • decreases in white blood cells (which can be fatal) LATUDA and medicines like it may raise the level of prolactin. Tell your health care provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence. Tell your health care provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures. Tell your health care provider if you experience prolonged, abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia. LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you. LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm. Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood. Tell your health care provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Tell your health care provider if you are allergic to any of the ingredients of LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your health care provider if you are not sure if you are taking any of these medications. Tell your health care provider if you are pregnant or if you are planning to get pregnant. Avoid breastfeeding while taking LATUDA. The most common side effects of LATUDA include sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea. These are not all the possible side effects of LATUDA. For more information, ask your health care provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call l-800-FDA-1088. Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.1,2 It affects approximately 12.6 million adults in the United States.3,4 Approximately 50 to 60 percent of adults with bipolar disorder experience their first symptoms during adolescence and it can be difficult to diagnose.5,6 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.7 Symptoms of bipolar disorder in children and adolescents can be severe and may cause young people to think about death or suicide during depressive episodes.8 Bipolar disorder is the fourth leading cause of disability among children and adolescents worldwide.9 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.10 Bipolar depression refers to the depressive phase of bipolar disorder;1 its symptoms include: depressed mood, loss of interest or pleasure in activities, significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and recurrent thoughts of death or suicide attempt.1 When symptomatic, depressive symptoms affect patients more commonly than manic symptoms.11 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,12,13 and are associated with increased risk of suicide and direct and indirect health care costs.14,15 Schizophrenia is a chronic, serious and often severely disabling brain disorder. Symptoms such as hallucinations and delusions usually start between ages 16 and 30.7 Other symptoms may include unusual or dysfunctional ways of thinking, agitated body movements, reduced expression of emotions and cognitive symptoms such as poor focus, memory or executive functioning.7 Although rare in young children, incidence of schizophrenia rises during adolescence and peaks in early adulthood.2 Adolescent schizophrenia is associated with poor functioning prior to the onset of illness and early developmental delays.2 Similar types of early developmental and social impairments have been reported in adult-onset schizophrenia, but appear to be more common and severe in adolescents.2 A diagnosis of schizophrenia in adolescence may be a predictor of less independence, poorer educational achievement, lower likelihood of employment or access to further education, higher global disability scores and poor social relationships in adulthood.8 Dasotraline is a new chemical entity that is considered to be a dopamine and norepinephrine reuptake inhibitor (DNRI). It has an extended half-life (47-77 hours) that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval. Dasotraline has shown a lower potential for abuse than methylphenidate in clinical testing.16 Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development to evaluate its use in treating attention deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). It has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD, BED or any other disorder. Binge eating disorder (BED) is characterized by recurrent episodes of binge eating that occur at least once per week for three months. An episode of binge eating is defined as eating an abnormally large amount of food in a discrete period of time. This is typically accompanied by a sense of lack of control. Binge eating must be characterized by marked distress and at least three of the following: eating more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of embarrassment and feeling disgusted, guilty or depressed afterwards.17 The lifetime prevalence of BED among adult women and men in the United States is 3.6 percent and 2.1 percent, respectively.18,19 BED typically begins in adolescence or young adulthood but can also start later.20 BED can lead to a number of psychological and physical problems, such as social isolation, feeling bad about oneself, problems functioning at work, obesity and related medical conditions (e.g., gastroesophageal reflux disease, joint problems, heart disease, type 2 diabetes and some sleep-related breathing disorders).21 It is also associated with increased health care utilization, medical morbidity and mortality.22 Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Brovana® (arformoterol tartrate) inhalation solution, Latuda® (lurasidone HCI) and Aptiom® (eslicarbazepine acetate). Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com. LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc. APTIOM is used under license from Bial. UTIBRON is a trademark of Novartis AG, used under license. NEOHALER is a registered trademark of Novartis AG, used under license. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. For a copy of this release, visit Sunovion’s web site at www.sunovion.com 1 Swann, AC. Long-term treatment in bipolar disorder. Journal of Clinical Psychiatry. 2005; 66(1):7-12. 2 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 3 National Institute of Mental Health. Bipolar Disorder. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml. Accessed April 2017. 4 “Bipolar Disorder.” Decision Resources. Table 2-2. Burlington, MA. December 2013. 5 Chang K. Dialogues Clin Neurosci. 2009; 11(1):73-80. 6 National Institute of Mental Health. Bipolar disorder in adults. [Internet]. Available from: http://www.nimh.nih.gov/health/publications/bipolar-disorder-tr-15-3679/index.shtml. Accessed April 2017. 7 Van Meter AR, Moreira AL, Youngstrom EA. Meta-analysis of epidemiologic studies of pediatric bipolar disorder. J Clin Psychiatry. 2001; 72(9): 1250-1256. 8 National Institute of Mental Health. Bipolar disorder in Children and Adolescents. [Internet]. Available from: http://www.nimh.nih.gov/health/publications/bipolar-disorder-in-children-and-adolescents/index.shtml. Accessed April 2017. 9 Gore FM, et al. Lancet 2011; 377(9783):2093-2102. 10 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 11 The Depression and Bipolar Support Alliance. Bipolar Disorder. [Internet]. Available from: http://www.dbsalliance.org/site/PageServer?pagename=education_bipolar. Accessed April 2017. 12 Huxley N, Baldessarini RJ. Disability and Its Treatment in Bipolar Disorder Patients. Bipolar Disorder. 2007; 9(1-2):183-96. 13 Calabrese JR, Hirschfeld RM, Frye MA, Reed ML. Impact Of Depressive Symptoms Compared With Manic Symptoms In Bipolar Disorder: Results Of A U.S. Community-Based Sample. Journal of Clinical Psychiatry. 2004; 65(11):1499-504. 14 Parker G, McCraw S, Hadzi-Pavlovic D, Fletcher K. Costs Of The Principal Mood Disorders: A Study Of Comparative Direct And Indirect Costs Incurred By Those With Bipolar I, Bipolar II And Unipolar Disorders. Journal of Affective Disorders. 2012; 149(1-3):46-55. (ePub). 15 Leverich GS, Altshuler LL, Frye MA, et al. Factors Associated With Suicide Attempts In 648 Patients With Bipolar Disorder In The Stanley Foundation Bipolar Network. Journal of Clinical Psychiatry. 2003; 64(5):506-15. 16 Koblan, KS, Hopkins SC, Sarma, K, et al. Assessment of Human Abuse Potential of Dasotraline Compared to Methylphenidate and Placebo in Recreational Stimulant Users. Drug Alcohol Dependence. 2015; 159: 26-34. 17 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 18 Hudson, JI, Hiripi, E, Pope, HG, & Kessler, RC. (2007). The Prevalence and Correlates of Eating Disorders in the National Comorbidity Survey Replication. Biological Psychiatry. 61(3), 348–58. 19 Smink, FRE, van Hoeken, D, & Hoek, HW. Epidemiology of Eating Disorders: Incidence, Prevalence and Mortality Rates. Current Psychiatry Reports. 2012; 14(4), 406–14. 20 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 21 Mayo Clinic. Binge-Eating Disorder: Symptoms and causes. [Internet]. Available from: http://www.mayoclinic.org/diseases-conditions/binge-eating-disorder/basics/complications/con-20033155. Accessed March 2017. 22 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013.


MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that results of a Phase 3 clinical study evaluating Latuda® (lurasidone HCI) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) showed statistically significant and clinically meaningful improvement in depressive symptoms compared to placebo. LATUDA is currently indicated in the U.S. for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate and for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age). The results were presented today at the 170th Annual Meeting of the American Psychiatric Association (APA) in San Diego, California. “ Children and adolescents with bipolar depression have significant functional impairment, including poor academic and social performance, and they are at very high risk for suicide attempts and self-injurious behavior,” said Kiki Chang, M.D., Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center. “ There are few evidence-based treatment options available to help these patients and their families. More treatments are needed that not only improve bipolar depression symptoms in children and adolescents, but are also well-tolerated.” “ It is encouraging to see the potential for LATUDA to help children and adolescents living with bipolar depression,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “ When bipolar depression strikes in younger years, it can be particularly disabling, so we’re pleased that in this placebo-controlled study, LATUDA improved depressive symptoms without causing significant weight gain or metabolic changes in children and adolescents.” These data have been submitted to the U.S. Food and Drug Administration (FDA) to support a supplemental New Drug Application (sNDA). In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents 10 to 17 years of age with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) total score (-21.0 vs. -15.3; effect size = 0.45, p<0.0001). Statistically significant and clinically relevant change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) was also seen with LATUDA compared to placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001). LATUDA also demonstrated statistically significant improvement on other secondary efficacy endpoints. LATUDA was generally well tolerated. The most common treatment-emergent adverse events (TEAEs) reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA was associated with no increases in fasting glucose or lipids, and minimal increase in mean weight vs. placebo (+0.74 kg vs. +0.44 kg). Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.1,2 It affects approximately 12.6 million adults in the United States.3,4 Approximately 50 to 60 percent of adults with bipolar disorder experience their first symptoms during adolescence and it can be difficult to diagnose.5,6 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.7 Symptoms of bipolar disorder in children and adolescents can be severe and may cause young people to think about death or suicide during depressive episodes.8 Bipolar disorder is the fourth leading cause of disability among children and adolescents worldwide.9 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.10 Bipolar depression refers to the depressive phase of bipolar disorder;1 its symptoms include: depressed mood, loss of interest or pleasure in activities, significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and recurrent thoughts of death or suicide attempt.1 When symptomatic, depressive symptoms affect patients more commonly than manic symptoms.11 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,12,13 and are associated with increased risk of suicide and direct and indirect health care costs.14,15 LATUDA is used to treat patients with: The efficacy of LATUDA was established in a 6-week monotherapy study and a 6-week adjunctive therapy study with lithium or valproate in adult patients with bipolar depression. The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies in adult patients and one 6-week placebo-controlled study in adolescents (13 to 17 years). The most common side effects of LATUDA include sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea. LATUDA is available in five tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. Please see Important Safety Information, including Boxed Warnings, below and full Prescribing Information at www.LATUDA.com. INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death compared to patients receiving placebo (sugar pill). LATUDA is not approved for the treatment of patients with dementia-related psychosis. Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. LATUDA is not approved for use in pediatric patients with depression. LATUDA can cause serious side effects, including stroke that can lead to death, which can happen in elderly people with dementia who take medicines like LATUDA. Neuroleptic malignant syndrome (NMS) is a rare but very serious condition that can happen in people who take antipsychotic medicines, including LATUDA. NMS can cause death and must be treated in a hospital. Call your health care provider right away if you become severely ill and have some or all of these symptoms: high fever, excessive sweating, rigid muscles, confusion, or changes in your breathing, heartbeat or blood pressure. Tardive dyskinesia (TD) is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD may also start after you stop taking LATUDA. Increases in blood sugar can happen in some people who take LATUDA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your health care provider should check your blood sugar before you start LATUDA and during therapy. Call your health care provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: feel very thirsty, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick to your stomach, feel confused, or your breath smells fruity. Increases in triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with LATUDA. You may not have any symptoms, so your health care provider may decide to check your cholesterol and triglycerides during your treatment with LATUDA. Some patients may gain weight while taking LATUDA. Your doctor should check your weight regularly. Tell your doctor if you experience any of these: • decreases in white blood cells (which can be fatal) LATUDA and medicines like it may raise the level of prolactin. Tell your health care provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence. Tell your health care provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures. Tell your health care provider if you experience prolonged, abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia. LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you. LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm. Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood. Tell your health care provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Tell your health care provider if you are allergic to any of the ingredients of LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your health care provider if you are not sure if you are taking any of these medications. Tell your health care provider if you are pregnant or if you are planning to get pregnant. Avoid breastfeeding while taking LATUDA. The most common side effects of LATUDA include sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation, and nausea. These are not all the possible side effects of LATUDA. For more information, ask your health care provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call l-800-FDA-1088. Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Brovana® (arformoterol tartrate) inhalation solution, Latuda® (lurasidone HCI) and Aptiom® (eslicarbazepine acetate). Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com. LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc. APTIOM is used under license from BIAL. UTIBRON is a trademark of Novartis AG, used under license. NEOHALER is a registered trademark of Novartis AG, used under license. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. For a copy of this release, visit Sunovion’s web site at www.sunovion.com 1 Swann, AC. Long-term treatment in bipolar disorder. Journal of Clinical Psychiatry. 2005; 66(1):7-12. 2 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 3 National Institute of Mental Health. Bipolar Disorder. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml. Accessed April 2017. 4 “Bipolar Disorder.” Decision Resources. Table 2-2. Burlington, MA. December 2013. 5 Chang K. Dialogues Clin Neurosci. 2009; 11(1):73-80. 6 National Institute of Mental Health. Bipolar disorder in adults. [Internet]. Available from: http://www.nimh.nih.gov/health/publications/bipolar-disorder-tr-15-3679/index.shtml. Accessed April 2017. 7 Van Meter AR, Moreira AL, Youngstrom EA. Meta-analysis of epidemiologic studies of pediatric bipolar disorder. J Clin Psychiatry. 2001; 72(9): 1250-1256. 8 National Institute of Mental Health. Bipolar disorder in Children and Adolescents. [Internet]. Available from: http://www.nimh.nih.gov/health/publications/bipolar-disorder-in-children-and-adolescents/index.shtml. Accessed April 2017. 9 Gore FM, et al. Lancet 2011; 377(9783):2093-2102. 10 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 11 The Depression and Bipolar Support Alliance. Bipolar Disorder. [Internet]. Available from: http://www.dbsalliance.org/site/PageServer?pagename=education_bipolar. Accessed April 2017. 12 Huxley N, Baldessarini RJ. Disability and Its Treatment in Bipolar Disorder Patients. Bipolar Disorder. 2007; 9(1-2):183-96. 13 Calabrese JR, Hirschfeld RM, Frye MA, Reed ML. Impact Of Depressive Symptoms Compared With Manic Symptoms In Bipolar Disorder: Results Of A U.S. Community-Based Sample. Journal of Clinical Psychiatry. 2004; 65(11):1499-504. 14 Parker G, McCraw S, Hadzi-Pavlovic D, Fletcher K. Costs Of The Principal Mood Disorders: A Study Of Comparative Direct And Indirect Costs Incurred By Those With Bipolar I, Bipolar II And Unipolar Disorders. Journal of Affective Disorders. 2012; 149(1-3):46-55. (ePub). 15 Leverich GS, Altshuler LL, Frye MA, et al. Factors Associated With Suicide Attempts In 648 Patients With Bipolar Disorder In The Stanley Foundation Bipolar Network. Journal of Clinical Psychiatry. 2003; 64(5):506-15.

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