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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:, and 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 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 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: 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: 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: 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: 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: Accessed March 2017.

Miskovic V.,Attention | Keil A.,Attention | Keil A.,University of Florida
Psychophysiology | Year: 2012

The capacity to associate neutral stimuli with affective value is an important survival strategy that can be accomplished by cell assemblies obeying Hebbian learning principles. In the neuroscience laboratory, classical fear conditioning has been extensively used as a model to study learning-related changes in neural structure and function. Here, we review the effects of classical fear conditioning on electromagnetic brain activity in humans, focusing on how sensory systems adapt to changing fear-related contingencies. By considering spatiotemporal patterns of mass neuronal activity, we illustrate a range of cortical changes related to a retuning of neuronal sensitivity to amplify signals consistent with fear-associated stimuli at the cost of other sensory information. Putative mechanisms that may underlie fear-associated plasticity at the level of the sensory cortices are briefly considered, and several avenues for future work are outlined. © 2012 Society for Psychophysiological Research.

Lang P.J.,Attention | Mcteague L.M.,Medical University of South Carolina | Bradley M.M.,Attention
Psychophysiology | Year: 2016

Evidence is presented supporting a dimension of defensive reactivity that varies across the anxiety disorder spectrum and is defined by physiological responses during threat-imagery challenges that covary with objective measures of psychopathology. Previous imagery studies of anxiety disorders are reviewed, highlighting that, regardless of contemporary diagnostic convention, reliable psychophysiological patterns emerge for patients diagnosed with circumscribed fear compared to those diagnosed with pervasive anxious-misery disorders. Based on the heuristic outlined by the Research Domain Criteria (RDoC) initiative, an exploratory transdiagnostic analysis is presented, based on a sample of 425 treatment-seeking patients from across the spectrum of DSM-IV anxiety diagnoses. Using a composite index of startle reflex and heart rate reactivity during idiographic fear imagery for each patient, a defensive dimension was defined by ranking patients from most defensively reactive to least reactive and then creating five groups of equivalent size (quintile; N=85). Subsequent analyses showed significant parallel trends of diminishing reactivity in both electrodermal and facial electromyographic reactions across this defensive dimension. Negative affectivity, defined by questionnaire and extent of functional interference, however, showed consistent, inverse trends with defensive reactivity-as reports of distress increased, defensive reactivity was increasingly attenuated. Notably, representatives of each principal diagnosis appeared in each quintile, underscoring the reality of pronounced within-diagnosis heterogeneity in defensive reactivity. In concluding, we describe our new RDoC research project, focusing on the assessment of brain circuit function as it determines hypo/hyperreactivity to challenge-somatic and autonomic-and may relate to patients' stress history and genetic inheritance. © 2016 Society for Psychophysiological Research.

Wolfe J.M.,Attention
Attention, Perception, and Psychophysics | Year: 2014

Visual working memory is a volatile, limited-capacity memory that appears to play an important role in our impression of a visual world that is continuous in time. It also mediates between the contents of the mind and the contents of that visual world. Research on visual working memory has become increasingly prominent in recent years. The articles in this special issue of Attention, Perception, & Psychophysics describe new empirical findings and theoretical understandings of the topic. © 2014, The Psychonomic Society, Inc.

Neutral cues, after being reliably paired with noxious events, prompt defensive engagement and amplified sensory responses. To examine the neurophysiology underlying these adaptive changes, we quantified the contrast-response function of visual cortical population activity during differential aversive conditioning. Steady-state visual evoked potentials (ssVEPs) were recorded while participants discriminated the orientation of rapidly flickering grating stimuli. During each trial, luminance contrast of the gratings was slowly increased and then decreased. Right-tilted gratings (CS+) were paired with loud white noise but left-tilted gratings (CS-) were not. The contrast-following waveform envelope of ssVEPs showed selective amplification of the CS+ only during the high-contrast stage of the viewing epoch. Findings support the notion that motivational relevance, learned in a time frame of minutes, affects vision through a response gain mechanism. © 2014 Society for Psychophysiological Research.

Ash E.L.,Attention
Aging Health | Year: 2011

As the worlds population continues to age, the issues of age-related memory impairment become increasingly important and relevant to individual health and quality of life, as well as an increasing public health and societal concern. The concept of mild cognitive impairment (MCI) has emerged as a response to the desire and need to identify an indolent clinical condition that would reliably predict progression to dementia, particularly Alzheimers disease (AD). As a result of decades of research in the field of neurodegeneration, it is becoming increasingly evident that neurodegenerative diseases begin years before the onset of clinical symptoms, and that standard clinical practice may be relatively insensitive at identifying early neurodegenerative states. The MCI concept was developed to identify the clinical parameters that define the earliest stages of the neurodegenerative process. The essence of the MCI classification is that of mild but measurable cognitive changes indicating a predisposition to progression to dementia, prior to the onset of functional decline. MCI and, more specifically, amnestic MCI were initially proposed as pathological transitional states that ultimately progress to full blown AD. However, after more than a decade of observations, it has been found that MCI subjects do not uniformly progress to dementia or AD and may revert back to normal cognitive states. While the concept of MCI may represent a valid model for characterization of the earliest stages of dementia and for delineation of risk factors, the operational definition may not adequately convey the intended concepts, and as such should be viewed with caution. Additional modifications to the concept and its operationalization are suggested in order to better identify patients with incipient AD and to guide clinical and research practices. © 2011 Future Medicine Ltd.

Ayeni O.R.,McMaster University | Alradwan H.,McMaster University | de Sa D.,McMaster University | Philippon M.J.,Attention
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2014

Purpose: With further understanding of the function and the importance of the hip labrum, greater attention has been paid to preserve and repair the damaged labrum. Hip labrum reconstruction has been described to optimize hip preservation when the labrum is deficient. This systematic review aimed to explore and identify the reported indications and outcomes in patients who undergo labral reconstruction of the hip joint. Methods: The electronic databases EMBASE, MEDLINE, and PubMed were searched for all available dates up to July 2013. Further hand search of the reference sections of the included studies was done. Two reviewers searched, screened, and evaluated the included studies for data quality using the Methodological Index for Non-Randomized Studies (MINORS) Scale. Data were also abstracted in duplicate, and agreement and descriptive statistics are presented. Results: There were 5 eligible studies (3 case series, 1 prospective cohort, and 1 retrospective chart review) with a total of 128 patients, and an average 11/16 quality on the MINORS score included in this review. All patients were diagnosed with femoroacetabular impingement and underwent labral reconstruction. Ninety-four patients were assessed at follow-up (73.4 % survivorship) between a reported mean range of 10 and 49 months. There was variability between the studies with regard to the graft types utilized (ilio-tibial band, Gracilis tendon, Ligamentum teres), surgical approaches [open (18.7 %) vs. arthroscopic (81.3 %)], and the reported outcome measures. Overall, improvement was observed in the patient-reported outcomes and functional scores (mHHS, HOS, UCLA, NASH, and SF-12). The failure rate or conversion to THA rate in all available patients was 20 %. The most common indication for labrum reconstruction was a young, active patient with minimal arthritis and non-salvageable or deficient labrum. Other indications included instability, pain, and hypotrophic dysfunctional labrum. Conclusion: Based on the current available evidence, hip labrum reconstruction is a new technique that shows short-term improvement in patient-reported outcomes and functional scores post-operatively. The main indication for reconstruction was a deficient labrum due to previous surgical excision or irreparable tears in young patients with no significant arthritis. Long-term follow-up results with higher quality studies are still lacking based on this review. Level of evidence: II. © 2013 Springer-Verlag Berlin Heidelberg.

McGinnis E.M.,Attention | Keil A.,Attention
PLoS ONE | Year: 2011

Identifying targets in a stream of items at a given constant spatial location relies on selection of aspects such as color, shape, or texture. Such attended (target) features of a stimulus elicit a negative-going event-related brain potential (ERP), termed Selection Negativity (SN), which has been used as an index of selective feature processing. In two experiments, participants viewed a series of Gabor patches in which targets were defined as a specific combination of color, orientation, and shape. Distracters were composed of different combinations of color, orientation, and shape of the target stimulus. This design allows comparisons of items with and without specific target features. Consistent with previous ERP research, SN deflections extended between 160-300 ms. Data from the subsequent P3 component (300-450 ms post-stimulus) were also examined, and were regarded as an index of target processing. In Experiment A, predominant effects of target color on SN and P3 amplitudes were found, along with smaller ERP differences in response to variations of orientation and shape. Manipulating color to be less salient while enhancing the saliency of the orientation of the Gabor patch (Experiment B) led to delayed color selection and enhanced orientation selection. Topographical analyses suggested that the location of SN on the scalp reliably varies with the nature of the to-be-attended feature. No interference of non-target features on the SN was observed. These results suggest that target feature selection operates by means of electrocortical facilitation of feature-specific sensory processes, and that selective electrocortical facilitation is more effective when stimulus saliency is heightened. © 2011 McGinnis and Keil.

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.

News Article | December 20, 2016

SMS Gateways are used heavily in high availability environments, as an interface to system and network monitoring applications. They provide a backup to Internet-based notifications, for those situations when the Internet is not available. SMS Gateways communicate directly with the cellular network, providing an alternate path to message delivery. The Attention! SMS Gateway is also used as an alternative to Cloud-based short code solutions. When implemented with the required number of SMS channels, the Attention! SMS Gateway allows organizations to send, and receive, SMS text messages to a large number of users, for a fixed monthly cost. By eliminating the need for a short code, and the per-message charge assessed by Cloud providers, organizations using the Attention! SMS Gateway can save thousands—and sometimes tens of thousands of dollars per year. “We have had many customers asking for CDMA support,” said Bob Lueth, President of Attention Software. “So many companies are dedicated Verizon shops, but were required to make a trip to the AT&T store to get SIM chips to support the Attention! SMS Gateway hardware. With full support for CDMA, they can now just order the required number of data plans from their Verizon representative, and they are up and running. They also like the fact that SMS transmissions are being sent, and received, on their own network.” The Attention! 4G/LTE SMS Gateway supports up to 4,096 channels of outbound, and inbound SMS communication. When users reply to messages sent by the Attention! SMS Gateway, their response is archived for later review. In addition, the Attention! SMS Gateway supports automated, programmatic responses to all replies, in real-time. This capability is often used to verify acknowledgement of the message, or provide updates to help desk and management systems. About Attention Software Since 1993, Attention Software, Inc. of Colorado Springs, CO. has provided alerting, alarm management and web-based messaging systems to organizations around the world. For more information on Attention Software, visit Attention® is a registered trademark of Attention Software, Inc. Other products mentioned herein may be trademarks and/or registered trademarks of their respective owners.

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