FDA Grants Fast Track Designation For Supernus' SPN-810 - Quick Facts

(RTTNews) - Supernus Pharmaceuticals, Inc.(SUPN) Thursday said the United States Food and Drug Administration or FDA has given fast track designation for its investigational drug SPN-810, for treating impulsive aggression in attention deficit hyperactivity disorder or ADHD. This product candidate is expected to enter last-stage trial, with patient dosing starting from 2015.

Fast track designation is entitled to those products, that are being investigated for treatment of serious conditions, and for which nonclinical or clinical data suggest that they may address an unmet medical need. The designation will enable early filing of some sections of the marketing application, and has the potential for an expedited review category for the New Drug Application.

Jack Khattar, CEO of the company said: "As a high-priority pipeline product, this designation reinforces our belief that SPN-810 can be a breakthrough product for treating patients with impulsive aggression. We look forward to working closely with the FDA to get this treatment to patients in an expedited manner."