Tris Pharma, Inc. ("Tris") announced that U.S. Food and Drug Administration ("FDA") has accepted 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 already 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 are profoundly effective in treating ADHD, current formulations are less than ideal for pediatric patients who have difficulty swallowing 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 an investigator in the Dyanavel XR Phase III study. "As an 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 and we will continue to innovate and improve patient care in this space."
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