Breaking News
July 16, 2018 - Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
July 16, 2018 - NSAIDs shown to have causal role in cardiovascular risk of patients with osteoarthritis
July 16, 2018 - PET scan tracer predicts success of cancer ‘vaccine’ | News Center
July 16, 2018 - Parents struggle with what to do when their child has headache, shows study
July 16, 2018 - Outrageous or overblown? HHS announces another round of ACA navigator funding cuts
July 16, 2018 - Weight loss surgery may impact individual’s risk of developing cancer, shows study
July 16, 2018 - Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
July 16, 2018 - Restoring epigenetic balance reinstates memory in flies with Alzheimer’s disease symptoms
July 16, 2018 - Magnetized wire could be used to detect cancer in people | News Center
July 16, 2018 - Non-surgical management found to be feasible option for penetrating kidney trauma
July 16, 2018 - California clinic screens asylum seekers for honesty
July 16, 2018 - FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
July 16, 2018 - Can nanotechnology help treat Alzheimer’s?
July 16, 2018 - Researchers identify protein essential for making stem cells | News Center
July 16, 2018 - Radiologist discusses causes, treatments of varicose veins
July 16, 2018 - Researchers develop nanostructured surface to accelerate wound healing after dental implants
July 16, 2018 - New non-invasive procedure to reposition kidney stones could benefit astronauts
July 16, 2018 - Attending Surgeon Influences Genetic Testing in Breast Cancer
July 16, 2018 - Medical doctors with addictions fear professional repercussions if they seek treatment
July 16, 2018 - 5 Questions: John Ioannidis calls for more rigorous nutrition research | News Center
July 16, 2018 - SUSU scientists develop rehabilitation device for people with lower limbs injuries
July 16, 2018 - Researchers find definite increase in scooter-related injuries
July 16, 2018 - Researchers solve mystery of final blood group system
July 16, 2018 - Researchers develop near-infrared fluorophores-based PDT to cure cancer with less side effects
July 16, 2018 - Traumatic brain injury biomarker could help predict patient prognosis
July 16, 2018 - Researchers to investigate role of hormones in mosquito’s ability to use human blood for egg production
July 16, 2018 - AHA: Doctor Makes Lifesaving House Call in His Own Home
July 16, 2018 - Nearsightedness – Genetics Home Reference
July 16, 2018 - Study shows biomarker panel boosts lung cancer risk assessment for smokers
July 16, 2018 - Researchers find link between bereavement during pregnancy, child’s mental health | News Center
July 16, 2018 - Legalizing same-sex marriage has meaningful effects on health care access for sexual-minority men
July 16, 2018 - New York to allow medical marijuana as substitute to opioids
July 16, 2018 - Reducing tapeworm infection could improve academic performance, reduce poverty | News Center
July 16, 2018 - Researchers describe key role of enzyme in regulating immune response against Chagas disease parasite
July 16, 2018 - Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV
July 16, 2018 - Do Racial and Gender Disparities Exist in Newer Glaucoma Treatments?
July 16, 2018 - Antibodies may predict transplant rejection risk
July 16, 2018 - New center sets out to stop disease before it starts | News Center
July 16, 2018 - FDA warns consumers about criminals sending fake warning letters
July 16, 2018 - Residential segregation linked with racial disparities in firearm homicide fatalities
July 16, 2018 - UW-Madison researchers develop new method to track Parkinson’s damage in the heart
July 16, 2018 - New approach to cultivate hypoallergenic tomato and strawberry varieties
July 16, 2018 - Smoking associated with delayed shinbone healing
July 16, 2018 - Sheila Dolezal, ‘team player extraordinaire,’ wins 2018 Amy J. Blue Award | News Center
July 16, 2018 - Advanced Prostate Cancer Variant More Common Than Thought
July 16, 2018 - New ways to conquer sleep apnea compete for place in bedroom
July 16, 2018 - Renowned microbe hunter Stanley Falkow dies at 84 | News Center
July 15, 2018 - FDA Slaps Stronger Warnings on Potent Class of Antibiotics, Fluoroquinolones
July 15, 2018 - Don’t let depression keep you from exercising
July 15, 2018 - Student research symposium showcases curiosity and scholarship | News Center
July 15, 2018 - Heavy smokers have increased risk of heart rhythm disorder, shows study
July 15, 2018 - Parents who had severe trauma, stresses in childhood more likely to have kids with behavioral health problems
July 15, 2018 - At colloquium, a range of views on value of predictive algorithms | News Center
July 15, 2018 - Pittcon invites oral and poster presentations for 2019 Technical Program
July 15, 2018 - Virtual reality could offer psychotherapy for fear of heights, study shows
July 15, 2018 - Retooled vaccine raises hopes as a lower-cost treatment for Type 1 diabetes
July 15, 2018 - Kolon TissueGene To Start US Phase III Clinical Trial For Invossa
July 15, 2018 - Study finds prenatal marijuana use can affect infant size, behavior
July 15, 2018 - Howard Chang named HHMI investigator | News Center
July 15, 2018 - Study shows tailored mental health services improve wellbeing of emerging adults
July 15, 2018 - A bright future might help teens steer clear of violence
July 15, 2018 - Stanford Medicine magazine explores the art, science of listening and hearing | News Center
July 15, 2018 - New study tracks how the brain turns simple sensory inputs into meaningful categories
July 15, 2018 - Deadlier subtype of metastatic prostate cancer found to be common than previously thought
July 15, 2018 - UZH scientists identify enzyme that controls cell division
July 15, 2018 - Unhealthy Food Behaviors May Signal Eating Disorder in Teen
July 15, 2018 - Study raises doubts on a previous theory of Parkinson’s disease
July 15, 2018 - Grant awarded to study whether stem cells can treat urinary incontinence | News Center
July 15, 2018 - Imaging techniques may help assess immune system recovery in HIV patients
July 15, 2018 - Machine-learning may aid in diagnosis and treatment of mental health disorders
July 15, 2018 - ‘Skin Cancer, Take A Hike!’ program promotes sun safety and skin cancer awareness
July 15, 2018 - Blink Health announces lowest prices for generic prescriptions through Blue Eagle Health
July 15, 2018 - New drug strategy can alleviate multiple behavioral, cellular deficiencies in FXS mouse model
July 15, 2018 - Georgia State professor receives federal grant to study virus similar to Ebola virus
July 15, 2018 - Quitting Smoking? Even a Little Exercise Can Help You Stay Slim
July 15, 2018 - DBS treatment may slow the progression of Parkinson’s tremor in early-stage patients
July 15, 2018 - 5 Questions: Luby on virus with potential to cause global pandemic | News Center
July 15, 2018 - Corn loses its cancer-fighting phenolic acids when processed into cornflakes
July 15, 2018 - Study uncovers possible link between iron loading, alcohol intake and mortality
July 15, 2018 - Molecular insights of NagA enzyme could help combat TB
Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

image_pdfDownload PDFimage_print

dasotraline

Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD

MARLBOROUGH, Mass.–(BUSINESS WIRE) November 10, 2017 –Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults.

The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year. In total, approximately 2,500 people with ADHD were evaluated in these studies, and dasotraline was generally well tolerated.

“While there are a number of approved treatments for people living with ADHD, there remains a significant need for novel therapies that can address the needs of patients,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We are pleased that the FDA has accepted our New Drug Application for dasotraline and look forward to working closely with the Agency so that we can bring this important treatment option to people with ADHD.”

About Dasotraline

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.

About Attention Deficit Hyperactivity Disorder (ADHD)

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).1 Approximately 11 percent of children four to 17 years of age have been diagnosed with ADHD in the United States.2 Up to 60 percent of children with ADHD continue to experience symptoms into adulthood.3 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.4

In children, ADHD is associated with social rejection and reduced school performance.5 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.6 In adults, symptoms reduce the quality of social or occupational functioning.5 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.7 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.8,9,10

About Sunovion Pharmaceuticals Inc.

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/or commercialization of important therapies has included Utibron™ Neohaler ® (indacaterol/glycopyrrolate) Inhalation Powder, Seebri™ Neohaler® (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 websites: 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 and SEEBRI are trademarks 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.

References

1 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013.
2 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.
3 Targum SD. & Adler LA. Our Current Understanding of Adult ADHD. Innovations in Clinical Neuroscience. 2014; 11(11-12): 30–35.
4 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.
5 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. Washington, DC: American Psychiatric Association, 2013.
6 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.
7 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.
8 Assessing Adults with ADHD and Comorbidities. Primary Care Companion to the Journal of Clinical Psychiatry. 2009;11(1): 25-43.
9 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.
10 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.

Source: Sunovion Pharmaceuticals Inc.

Posted: November 2017

Related Articles

dasotraline FDA Approval History

Tagged with:

About author

Related Articles