This product candidate is expected to enter Phase III testing, with patient dosing commencing during 2015. Fast track designation is for 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.
Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
The fast track designation allows for more frequent interactions between the FDA and the Company, allows for the early submission of some sections of the marketing application, and carries the potential for an expedited review category for the New Drug Application.
"We are pleased that the FDA has approved our application for a fast track designation for SPN-810," said Jack Khattar, President and Chief Executive Officer for Supernus Pharmaceuticals, Inc.
"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."