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"We congratulate Orient Pharma on the results of this trial and look forward to their pursuing a new drug application with the Taiwan Food and Drug Administration," said James E. Brown, President and CEO of DURECT Corporation.  "On our part, we intend to reach out with this Phase 3 data to potential development and commercialization partners for major markets not licensed to Orient Pharma." This was a Phase 3, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study designed to demonstrate the efficacy and safety of ORADUR-Methylphenidate ER Capsule in children and adolescents with ADHD aged 6 to 18 years.  There were 110 subjects enrolled in this study, of which 99 evaluable subjects completed the study.  The primary efficacy measure in this study was to demonstrate superiority of ORADUR-Methylphenidate ER Capsule over placebo using the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form score.  The SNAP-IV rating scale contains 26 questions, classified as three components of ADHD symptoms (inattention, hyperactivity/impulsivity and oppositional defiant disorder). For the primary efficacy endpoint, ORADUR-Methylphenidate ER Capsule was superior to placebo in a statistically significant manner (p=0.0044 for the intent to treat population and p=0.0032 for the per protocol population). There were no serious adverse events in this pivotal study.  Orient Pharma's safety analysis indicates that the incidence of adverse events was generally consistent with other ADHD products. About Attention Deficit Hyperactivity Disorder (ADHD) ADHD is a neurobehavioral condition that is estimated to affect over 5 million (approximately 9%) of U.S. children ages 3-17, according to the U.S. Department of Health and Human Services. The prevalence of ADHD in Taiwan has been reported to be approximately 5-7% among school children.  The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition presents itself in childhood and can be life long as a significant number of children with ADHD continue to present symptoms as adults. It is estimated that over 50% of children with ADHD in the U.S. are being treated by medication, with stimulants such as amphetamine or methylphenidate as first-line treatments. U.S. sales of ADHD treatments were approximately $10.4 billion in 2016. The 2010 National Survey on Drug Use & Health estimates that 1.1 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness. ORADUR-Methylphenidate ER Capsule is an investigational product candidate for the treatment of ADHD.  This drug candidate is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of methylphenidate, a commonly prescribed first-line treatment for ADHD. ORADUR-Methylphenidate ER Capsule is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration, the Taiwan Food and Drug Administration or other health authorities. In August 2009, DURECT entered into a development and license agreement with Orient Pharma, a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which we granted to Orient Pharma development and commercialization rights in certain defined Asian and South Pacific countries to ORADUR-Methylphenidate ER Capsule. We retain rights to North America, Europe, Japan and all other countries not specifically licensed to Orient Pharma.  If commercialized, we will be entitled to receive a royalty on sales of ORADUR-Methylphenidate ER Capsule by Orient Pharma. Orient Pharma has committed to supply a portion of our commercial requirements in territories other than the United States for ORADUR-Methylphenidate ER Capsule. ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added potential benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today. DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms.  DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program.  An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival.  Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis.  DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery.  Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT's ORADUR® technology.  For more information, please visit www.durect.com. NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. POSIMIR, DUR-928 and REMOXY ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities. The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of ORADUR-Methylphenidate ER Capsule to treat ADHD with once-a-day dosing and tamper-resistant characteristics, the potential use of DUR-928 to treat NAFLD, NASH, other liver diseases, acute organ injury or inflammatory skin conditions such as psoriasis and the potential use of POSIMIR to provide 3 days of continuous pain relief after surgery are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the development program for ORADUR-Methylphenidate ER Capsule or POSIMIR will not support successful NDA submissions or product approvals, possible adverse events associated with the use of these product candidates, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of these product candidates, the ability to manufacture, commercialize and obtain marketplace acceptance of these product candidates, if approved, and avoid infringing patents held by other parties and secure and defend patents of our own, and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on May 10, 2017 under the heading "Risk Factors."


News Article | June 28, 2017
Site: www.prlog.org

FBT Bank and Mortgage and FHLB Dallas Provided Funds for Elderly Woman -- When retired seamstress Darlene Harper learned about the Special Needs Assistance Program (SNAP) from a friend, it seemed like the answer to a number of problems with her home that she could not afford to repair.Nearly $6,000 in SNAP funds from the Federal Home Loan Bank of Dallas (FHLB Dallas) and FBT Bank and Mortgage repaired the back door of her home, which was built in the 1970s, the front porch, as well as replaced the floor in her bathroom. Ms. Harper's grant is part of $355,455 in grant funds FHLB Dallas has awarded through FBT Bank and Mortgage since SNAP's inception in 2009. The grants have helped 57 Arkansas families."The floor was about to fall in!" said Ms. Harper. "The grant was a blessing because now I can be comfortable in my house again."SNAP grants assist income-qualified, special-needs homeowners with necessary home repairs and modifications. The grants are awarded by FHLB Dallas through participating member institutions, such as FBT Bank and Mortgage.FBT Bank and Mortgage Vice President Scott Smith worked with Ms. Harper on the SNAP application. He said that by offering the SNAP program, FBT Bank and Mortgage is fulfilling its mission to serve the community."Thanks to SNAP and our partnership with FHLB Dallas, we're able to help Ms. Harper live more comfortably,"said Mr. Smith. "That's what being a community bank is all about."Since SNAP's inception in 2009, more than $11.6 million has been awarded in grants through FHLB Dallas member institutions to assist more than 2,300 families across FHLB Dallas' five-state District of Arkansas, Louisiana, Mississippi, New Mexico and Texas. In 2016, FHLB Dallas awarded nearly $1 million in SNAP grants that assisted 205 families. The 2017 SNAP funding, made available in January on a first-come, first-served basis, has been exhausted."The purpose of community investment programs such as SNAP is to make life easier for our members' customers," said Greg Hettrick, first vice president and director of Community Investment at FHLB Dallas. "We're proud to partner with FBT Bank and Mortgage as they commit to making their community a better place to live for seniors."Ms. Harper said that life is better now."I couldn't live comfortably with the problems I was having in my house," said Ms. Harper. "Now, life is much better and I'm so glad of that."To learn more about SNAP, visit http://www.fhlb.com/ snap ).The Federal Home Loan Bank of Dallas is one of 11 district banks in the FHLBank System created by Congress in 1932. FHLB Dallas, with total assets of $57.5 billion as of March 31, 2017, is a member-owned cooperative that supports housing and community investment by providing competitively priced loans and other credit products to approximately 850 members and associated institutions in Arkansas, Louisiana, Mississippi, New Mexico and Texas. For more information, visit http://www.fhlb.com/ ).


MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced positive results of a pivotal Phase 2/3 study (SEP360-221) evaluating the efficacy and safety of novel drug candidate dasotraline in adults 18 to 55 years of age with moderate to severe binge eating disorder (BED). Dasotraline, a dopamine and norepinephrine reuptake inhibitor (DNRI), showed significant reductions in the frequency of binge eating days per week compared to placebo and was generally well tolerated.1 The full study results were presented in a poster session today at the 170th Annual Meeting of the American Psychiatric Association (APA) in San Diego, California. “ Binge eating disorder is the most common eating disorder in adults in the United States and has the potential for serious, long-term health implications if left untreated,” said Susan L. McElroy, M.D., Chief Research Officer at Lindner Center of HOPE, Professor of Psychiatry and Behavioral Neuroscience at the University of Cincinnati College of Medicine. “ Continued study of BED is important, as effective treatment options which are well tolerated are needed for those living with this condition.” These results add to a large and growing body of data on dasotraline. Sunovion plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in fiscal year 2017 (April 2017-March 2018) for the treatment of attention deficit hyperactivity disorder (ADHD), as well as a supplemental New Drug Application (sNDA) for the treatment of BED in fiscal year 2018 (April 2018-March 2019). “ We are encouraged by these results suggesting that dasotraline may offer a novel, well-tolerated and efficacious treatment for binge eating disorder,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “ Limited treatment options are available for this challenging illness, and there is a substantial need for additional well-tolerated and effective therapies.” In this study, adults 18 to 55 years of age taking flexibly-dosed dasotraline 4-8 mg/day experienced statistically significant and clinically meaningful improvement compared to placebo on the primary endpoint, change from baseline in the number of binge eating days per week at Week 12 (p< 0.0001) with an effect size (ES) of 0.74. Dasotraline treatment was also associated with statistically significant improvement on all key secondary efficacy assessments: Clinical Global Impression of Severity of Illness Scale (CGI-S), the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) and percent of subjects with four-week cessation of binge eating. Change from baseline in CGI-S and YBOCS-BE scores was statistically significant, favoring dasotraline over placebo (ES=0.95 and 0.96, respectively, p<0.0001), and 46.5 percent of participants in the dasotraline group achieved at least four consecutive weeks cessation of binge eating versus 20.6 percent in the placebo group (p<0.0001). Dasotraline was generally well tolerated with an adverse event (AE) profile consistent with completed adult studies. The most common treatment-emergent adverse events (TEAEs) (reported in 5 percent or more of patients and greater than placebo) included insomnia, dry mouth, decreased appetite, anxiety, nausea, headache, decreased weight, dizziness, irritability, diarrhea, dyspepsia, constipation and thirst. The SEP360-221 study was a Phase 2/3, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, flexible-dose study comparing dasotraline with placebo in 317 adults (18 to 55 years of age) with moderate to severe BED in the U.S. Dasotraline was flexibly dosed once-daily in doses ranging from 4 to 8 mg or placebo. The primary endpoint was the change from baseline in number of binge eating days (defined as days during which at least one binge episode occurs) per week at Week 12. Secondary efficacy endpoints included Clinical Global Impression of Severity of Illness Scale (CGI-S), the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) and percent of subjects with four-week cessation from binge eating. 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.2 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.3 The lifetime prevalence of BED among adult women and men in the United States is 3.6 percent and 2.1 percent, respectively.4,5 BED typically begins in adolescence or young adulthood but can also start later.6 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).7 It is also associated with increased health care utilization, medical morbidity and mortality.8 Attention deficit hyperactivity disorder (ADHD) is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning and development, as characterized by inattention (e.g., distractibility, forgetfulness) and/or hyperactivity and impulsivity (e.g., fidgeting, restlessness).9 Approximately 11 percent of children four to 17 years of age have been diagnosed with ADHD in the United States.10 Up to 60 percent of children with ADHD continue to experience symptoms into adulthood.11 It is estimated that 4.4 percent of adults between ages 18 and 44 years experience some symptoms and disabilities from ADHD in the U.S.12 In children, ADHD is associated with social rejection and reduced school performance.13 Children with a history of ADHD are ten times as likely to have difficulties with friendships and can have more frequent and severe injuries than peers without ADHD.14 In adults, symptoms reduce the quality of social or occupational functioning.15 Studies have shown that ADHD is associated with higher levels of unemployment, and those who are employed may experience workplace impairment, reduced productivity and behavioral issues.16 Adults with ADHD are also at increased risk of trauma, workplace injuries and traffic accidents, are more likely to be diagnosed with comorbid mental health conditions and have a higher incidence of separation and divorce.17,18,19 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. © 2017 Sunovion Pharmaceuticals Inc. For a copy of this release, visit Sunovion’s web site at www.sunovion.com. 1 Data on file, Sunovion Pharmaceuticals Inc. 2 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. 3 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 4 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. 5 Smink, FRE, van Hoeken, D, & Hoek, HW. Epidemiology of Eating Disorders: Incidence, Prevalence and Mortality Rates. Current Psychiatry Reports. 2012; 14(4), 406–14. 6 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 7 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. 8 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 9 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 10 Centers for Disease Control and Prevention. Attention-Deficit / Hyperactivity Disorder (ADHD): Data and Statistics. [Internet]. Available from: http://www.cdc.gov/ncbddd/adhd/data.html. Accessed March 2017. 11 Targum SD. & Adler LA. Our Current Understanding of Adult ADHD. Innovations in Clinical Neuroscience. 2014; 11(11-12): 30–35. 12 National Resource Center on ADHD. General Prevalence of ADHD [Internet]. Available from: http://www.help4adhd.org/Understanding-ADHD/About-ADHD/Data-and-Statistics/General-Prevalence.aspx. Accessed March 2017. 13 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 14 Centers for Disease Control and Prevention. Attention-Deficit / Hyperactivity Disorder (ADHD): Other Concerns & Conditions. [Internet]. Available from: http://www.cdc.gov/ncbddd/adhd/conditions.html. Accessed March 2017. 15 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 16 Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of Attention-Deficit/Hyperactivity Disorder on Occupational Health in Adults and Adolescents. International Archives of Occupational and Environmental Health. 2012: 85(8), 837-47. 17 Assessing Adults with ADHD and Comorbidities. Primary Care Companion to the Journal of Clinical Psychiatry. 2009;11(1): 25-43. 18 Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of Attention-Deficit/Hyperactivity Disorder on Occupational Health in Adults and Adolescents. International Archives of Occupational and Environmental Health. 2012: 85(8), 837-47. 19 WebMD. Attention Deficit Hyperactivity Disorder in Adults [Internet]. Available from: http://www.webmd.com/add-adhd/guide/adhd-adults?page=2#2. Accessed March 2017.


News Article | June 12, 2017
Site: www.prnewswire.com

CASTLETON ON HUDSON, N.Y., June 12, 2017 /PRNewswire/ -- Attention to Detail announces the release of Easy Rafters 4.0, the latest version of its interactive roof design software for builders, remodelers, architects, engineers and do-it-yourselfers. Easy Rafters has been...


News Article | September 14, 2017
Site: www.businesswire.com

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) will present 10 research posters on Latuda® (lurasidone HCI) and five posters on the investigational agent dasotraline at the 30th Annual Psych Congress, which will be held September 16-19, 2017, in New Orleans, Louisiana. LATUDA is an atypical antipsychotic agent approved in the United States for the treatment of schizophrenia in adults and adolescents (13 to 17 years of age) and 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. Dasotraline is a novel, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being investigated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults and binge eating disorder (BED) in adults. “At Sunovion, we are dedicated to research and innovation in psychiatry, neurology and associated behavioral health conditions,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “Posters presented at this year’s Psych Congress reflect the continued study and development of lurasidone for both adult and pediatric patients with serious mental illness and of our investigational agent dasotraline for the treatment of patients with ADHD and binge eating disorder.” LATUDA is used to treat patients with: The efficacy of LATUDA was established in a 6-week placebo-controlled monotherapy study and a 6-week placebo-controlled 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 placebo-controlled studies in adult patients and one 6-week placebo-controlled study in adolescents (13 to 17 years of age). 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: 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. Dasotraline is a new chemical entity that acts as a dual dopamine and norepinephrine reuptake inhibitor (DNRI). It has an extended half-life (47-77 hours) that supports the potential for stable plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval. 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 or BED. Schizophrenia is a chronic, serious and often severely disabling brain disorder. Symptoms such as hallucinations and delusions usually start between ages 16 and 30. Other symptoms may include unusual or dysfunctional ways of thinking, agitated body movements, reduced expression of emotions and cognitive symptoms such as poor attention, memory or executive functioning.1 Although rare in young children, incidence of schizophrenia rises during adolescence and peaks in early adulthood. Adolescent schizophrenia is associated with poor functioning prior to the onset of illness and early developmental delays. 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.3 Bipolar disorder is a mental health condition that is characterized by potentially debilitating mood swings, including periods of depression and mania.4,5 It affects approximately 12.6 million adults in the United States.6,7 Approximately 50 to 60 percent of adults with bipolar disorder experience their first symptoms during adolescence and it can be difficult to diagnose.8,9 Pediatric bipolar disorder affects approximately 1.7 percent of children and adolescents in the United States.10 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.11 Bipolar disorder is the fourth leading cause of disability among children and adolescents worldwide.12 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.13 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.14 Depressive episodes associated with bipolar disorder have been shown to result in significant impairment in work, family and social function,15,16 and are associated with increased risk of suicide and direct and indirect health care costs.17,18 Attention deficit hyperactivity disorder (ADHD) is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning and development, as characterized by inattention (e.g., distractibility, forgetfulness) and/or hyperactivity and impulsivity (e.g., fidgeting, restlessness).19 Approximately 11 percent of children four to 17 years of age have been diagnosed with ADHD in the United States.20 Up to 60 percent of children with ADHD continue to experience symptoms into adulthood.21 It is estimated that 4.4 percent of adults between ages 18 and 44 years experience some symptoms and disabilities from ADHD in the U.S.22 In children, ADHD is associated with social rejection and reduced school performance.23 Children with a history of ADHD are 10 times as likely to have difficulties with friendships and can have more frequent and severe injuries than peers without ADHD.24 In adults, symptoms reduce the quality of social or occupational functioning.25 Studies have shown that ADHD is associated with higher levels of unemployment, and those who are employed may experience workplace impairment, reduced productivity and behavioral issues.26 Adults with ADHD are also at increased risk of trauma, workplace injuries and traffic accidents, are more likely to be diagnosed with comorbid mental health conditions and have a higher incidence of separation and divorce.27,28,29 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.30 The lifetime prevalence of BED among adult women and men in the United States is 3.6 percent and 2.1 percent, respectively.31,32 BED typically begins in adolescence or young adulthood but can also start later.33 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).34 It is also associated with increased health care utilization, medical morbidity and mortality.35 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, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, 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 a registered trademark of BIAL, used under license. 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. © 2017 Sunovion Pharmaceuticals Inc. All rights reserved. For a copy of this release, visit Sunovion’s web site at www.sunovion.com 1 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed January 2017. 2 Hollis, C. BJPsych Advances. 2015; 21:333–341. 3 Hollis, C. Am J Psychiatry. 2000; 157:1652-1659. 4 Swann, AC. Long-term treatment in bipolar disorder. Journal of Clinical Psychiatry. 2005; 66(1):7-12. 5 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 6 National Institute of Mental Health. Bipolar Disorder. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml. Accessed April 2017. 7 “Bipolar Disorder.” Decision Resources. Table 2-2. Burlington, MA. December 2013. 8 Chang K. Dialogues Clin Neurosci. 2009; 11(1):73-80. 9 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. 10 Van Meter AR, Moreira AL, Youngstrom EA. Meta-analysis of epidemiologic studies of pediatric bipolar disorder. J Clin Psychiatry. 2001; 72(9): 1250-1256. 11 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. 12 Gore FM, et al. Lancet 2011; 377(9783):2093-2102. 13 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 14 The Depression and Bipolar Support Alliance. Bipolar Disorder. [Internet]. Available from: http://www.dbsalliance.org/site/PageServer?pagename=education_bipolar. Accessed April 2017. 15 Huxley N, Baldessarini RJ. Disability and Its Treatment in Bipolar Disorder Patients. Bipolar Disorder. 2007; 9(1-2):183-96. 16 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. 17 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). 18 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. 19 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 20 Centers for Disease Control and Prevention. Attention-Deficit / Hyperactivity Disorder (ADHD): Data and Statistics. [Internet]. Available from: http://www.cdc.gov/ncbddd/adhd/data.html. Accessed March 2017. 21 Targum SD. & Adler LA. Our Current Understanding of Adult ADHD. Innovations in Clinical Neuroscience. 2014; 11(11-12): 30–35. 22 National Resource Center on ADHD. General Prevalence of ADHD [Internet]. Available from: http://www.help4adhd.org/Understanding-ADHD/About-ADHD/Data-and-Statistics/General-Prevalence.aspx. Accessed March 2017. 23 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 24 Centers for Disease Control and Prevention. Attention-Deficit / Hyperactivity Disorder (ADHD): Other Concerns & Conditions. [Internet]. Available from: http://www.cdc.gov/ncbddd/adhd/conditions.html. Accessed March 2017. 25 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 26 Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of Attention-Deficit/Hyperactivity Disorder on Occupational Health in Adults and Adolescents. International Archives of Occupational and Environmental Health. 2012: 85(8), 837-47. 27 Assessing Adults with ADHD and Comorbidities. Primary Care Companion to the Journal of Clinical Psychiatry. 2009;11(1): 25-43. 28 Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of Attention-Deficit/Hyperactivity Disorder on Occupational Health in Adults and Adolescents. International Archives of Occupational and Environmental Health. 2012: 85(8), 837-47. 29 WebMD. Attention Deficit Hyperactivity Disorder in Adults [Internet]. Available from: http://www.webmd.com/add-adhd/guide/adhd-adults?page=2#2. Accessed March 2017. 30 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 31 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. 32 Smink, FRE, van Hoeken, D, & Hoek, HW. Epidemiology of Eating Disorders: Incidence, Prevalence and Mortality Rates. Current Psychiatry Reports. 2012; 14(4), 406–14. 33 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013. 34 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. 35 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013.


Liu Y.,University of Florida | Huang H.,University of Florida | McGinnis-Deweese M.,Attention | Keil A.,Attention | Ding M.,University of Florida
Journal of Neuroscience | Year: 2012

The late positive potential (LPP) is a reliable electrophysiological index of emotional perception in humans. Despite years of research, the brain structures that contribute to the generation and modulation of LPP are not well understood. Recording EEG and fMRI simultaneously, and applying a recently proposed single-trial ERP analysis method, we addressed the problem by correlating the single-trial LPP amplitude evoked by affective pictures with the blood oxygen level-dependent (BOLD) activity. Three results were found. First, relative to neutral pictures, pleasant and unpleasant pictures elicited enhanced LPP, as well as heightened BOLD activity in both visual cortices and emotion-processing structures such as amygdala and prefrontal cortex, consistent with previous findings. Second, the LPP amplitude across three picture categories was significantly correlated with BOLD activity in visual cortices, temporal cortices, amygdala, orbitofrontal cortex, and insula. Third, within each picture category, LPP-BOLD coupling revealed category-specific differences. For pleasant pictures, the LPP amplitude was coupled with BOLD in occipitotemporal junction, medial prefrontal cortex, amygdala, and precuneus, whereas for unpleasant pictures significant LPP-BOLD correlation was observed in ventrolateral prefrontal cortex, insula, and posterior cingulate cortex. These results suggest that LPP is generated and modulated by an extensive brain network composed of both cortical and subcortical structures associated with visual and emotional processing and the degree of contribution by each of these structures to the LPP modulation is valence specific. © 2012 the authors.


Wieser M.J.,University of Würzburg | Keil A.,Attention
Journal of Neuroscience | Year: 2011

Models of visual selective attention have suggested that the representation of specific features characterizing a target object is enhanced in the visual cortex, at the cost of competing task-irrelevant information. In psychophysical studies, however, such attentional enhancement has been shown to result in reduced perceptual sensitivity when maintained over periods of several seconds. Two experiments examined the relationship between target detection behavior and electrocortical facilitation in human visual cortex during sustained attention under competition, in near real time. Steady-state visual evoked potentials (ssVEPs) were used in a change detection paradigm, in which a stream of flickering grating stimuli containing target events was fully overlapping with distractor faces (experiment 1) or competing complex scenes (experiment 2), covering the same part of the visual field. Beamformer source localization was used to test plausibility of lower-tier visual cortex involvement in modulation of the ssVEP signal. Results of both experiments suggest that early overallocation of visual cortical resources to the attended stimulus stream is associated with rapid reduction of electrocortical facilitation and poor change detection across the entire trial. By contrast, temporally balanced dynamics in visual cortex predicted accurate change detection. Together, the present results support models of sustained selective attention that emphasize competition for resources in lower-tier visual cortex. These models can be extended by a temporal dimension, on which attentive behavior is characterized by frugal resource sharing across the viewing time. © 2011 the authors.


Miskovic V.,Attention | Keil A.,Attention
Journal of Neuroscience | Year: 2013

Previous findings have established that cortical sensory systems exhibit experience-dependent biases toward stimuli consistently associated with threat. It remains unclear whether safety cues also facilitate perceptual engagement or how competition between learned threat and safety cues is resolved within visual cortex. Here, we used classical discrimination conditioning with simple luminance modulated visual stimuli that predicted the presence or absence of an aversive sound to examine visuocortical competition between features signaling threat versus safety. We tracked steady-state visual evoked potentials to label distinct visual cortical responses in humans to conditioned and control stimuli. Trial-by-trial expectancy ratings collected online confirmed that participants discriminated between threat and safety cues. Conditioning was associated with heightened activation of the extended visual cortex in response to the threat, but not the safety, stimulus. Cortical facilitation for the threatening stimulus was selective and not decreased by simultaneously presenting safe and associatively novel cues. Our findings shed light on the sensory brain dynamics associated with experiencedependent acquisition of perceptual biases for danger and safety signals. © 2013 the authors.


Wieser M.J.,University of Würzburg | Keil A.,Attention
NeuroImage | Year: 2014

Perception of facial expressions is typically investigated by presenting isolated face stimuli. In everyday life, however, faces are rarely seen without a surrounding visual context that affects perception and interpretation of the facial expression. Conversely, fearful faces may act as a cue, heightening the sensitivity of the visual system to effectively detect potential threat in the environment. In the present study, we used steady-state visually evoked potentials (ssVEPs) to examine the mutual effects of facial expressions (fearful, neutral, happy) and affective visual context (pleasant, neutral, threat). By assigning two different flicker frequencies (12 vs. 15. Hz) to the face and the visual context scene, cortical activity to the concurrent stimuli was separated, which represents a novel approach to independently tracking the cortical processes associated with the face and the context. Twenty healthy students viewed flickering faces overlaid on flickering visual scenes, while performing a simple change-detection task at fixation, and high-density EEG was recorded. Arousing background scenes generally drove larger ssVEP amplitudes than neutral scenes. Importantly, background and expression interacted: When viewing fearful facial expressions, the ssVEP in response to threat context was amplified compared to other backgrounds. Together, these findings suggest that fearful faces elicit vigilance for potential threat in the visual periphery. © 2013 Elsevier Inc.


McTeague L.M.,Attention | Lang P.J.,Attention
Depression and Anxiety | Year: 2012

Guided by the diagnostic nosology, anxiety patients are expected to show defensive hyperarousal during affective challenge, irrespective of the principal phenotype. In the current study, patients representing the whole spectrum of anxiety disorders (i.e., specific phobia, social phobia, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder (GAD), posttraumatic stress disorder(PTSD)), and healthy community control participants, completed an imagery-based fear elicitation paradigm paralleling conventional intervention techniques. Participants imagined threatening and neutral narratives as physiological responses were recorded. Clear evidence emerged for exaggerated reactivity to clinically relevant imagery-most pronounced in startle reflex responding. However, defensive propensity varied across principal anxiety disorders. Disorders characterized by focal fear and impairment (e.g., specific phobia) showed robust fear potentiation. Conversely, for disorders of long-enduring, pervasive apprehension and avoidance with broad anxiety and depression comorbidity (e.g., PTSDsecondary to cumulative trauma, GAD), startle responses were paradoxically diminished to all aversive contents. Patients whose expressed symptom profiles were intermediate between focal fearfulness and broad anxious-misery in both severity and chronicity exhibited a still heightened but more generalized physiological propensity to respond defensively. Importantly, this defensive physiological gradient-the inverse of self-reported distress-was evident not only between but also within disorders. These results highlight that fear circuitry could be dysregulated in chronic, pervasive anxiety, and preliminary functional neuroimaging findings suggest that deficient amygdala recruitment could underlie attenuated reflex responding. In summary, adaptive defensive engagement during imagery may be compromised by long-term dysphoria and stress-a phenomenon with implications for prognosis and treatment planning. © 2012 Wiley Periodicals, Inc.

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