Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Dyanavel XR (amphetamine) Extended-Release Oral Suspension, a CII controlled substance.
The NDA submission for Dyanavel XR was based on a Phase 3 multicenter, efficacy study conducted in over 100 patients. Results from the trial demonstrated a positive outcome by meeting all the primary endpoints.
Dyanavel XR is being developed using Tris’ innovative technology, LiquiXR, which has already been used to create other products. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October 2015.
For more information call (732) 940-2800 or visit TrisPharma.com.