Progressive MS Update: Opexa’s Tovaxin(R) for the Treatment of Multiple Sclerosis Granted Fast Track Designation by FDA

THE WOODLANDS, Texas, Nov 08, 2011 (BUSINESS WIRE) — Opexa Therapeutics, Inc.  announced today that its lead drug candidate Tovaxin(R) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. According to the FDA, products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review. Additionally, as per the FDA, Fast Track priority review products are more likely to be approved on the first review cycle than those without the designation. Fast Track also entitles Opexa to more frequent interactions and dialogue with the FDA, further benefiting the development of Tovaxin.