Healthcare Industry News: S.A.
News Release - May 21, 2015
Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel(TM) XR
The First, Once-Daily, Extended-Release Amphetamine-based Oral Liquid for the Treatment of ADHDMONMOUTH JUNCTION, N.J., May 21, 2015 -- (Healthcare Sales & Marketing Network) -- Tris Pharma, Inc. ("Tris") announced that U.S. Food and Drug Administration ("FDA") haS.A.cepted for review its New Drug Application ("NDA") for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October, 2015.
Dyanavel XR was developed using Tris' innovative technology, LiquiXR®, which haS.A.ready produced several breakthrough products. The NDA submission was based on a multicenter, phase III efficacy study conducted in over 100 patients, which demonstrated a positive outcome by meeting all its primary end points.
"Even though amphetamineS.A.e profoundly effective in treating ADHD, current formulationS.A.e less than ideal for pediatric patients who have difficulty S.A.lowing pills. Capsule formulations may be sprinkled or dissolved but patients may not ingest all of the product or worse, may chew the sprinkles causing dose dumping," said Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, who waS.A. investigator in the Dyanavel XR Phase III study. "AS.A. ER liquid amphetamine formulation, with a great duration of action, Dyanavel XR has the potential to fulfill an important unmet patient need."
Sally Berry, MD, PhD, Chief Medical Officer of Tris commented, "We are proud to have completed our clinical program studying the safety and efficacy of Dyanavel XR in children with ADHD. We look forward to working with the FDA throughout the review process. ADHD has long been a focal point for TriS.A.d we will continue to innovate and improve patient care in this S.A.e."
About Tris Pharma
Tris Pharma iS.A.specialty pharmaceutical company focused on the reS.A.ch and development of technologies-driven products. Tris has pioneered the delivery of suS.A.ned release in the liquid, chewable/ODT and strip dosage forms so patients do not have to S.A.low a pill. Tris' Nobuse™ technology provideS.A.use deterrence for opioidS.A.d other abuse-prone drugs. Tris' R&D and manufacturing facilitieS.A.e located in Monmouth Junction, New Jersey, U.S.A.
For more information, please visit www.trispharma.com
Source: Tris Pharma
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