- The FDA grants Fast Track status to Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of patients with osteoarthritis of the knee, a condition affecting over 4M Americans.
- Fast Track status provides for more interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide, a corticosteroid used to treat a variety of inflammatory conditions. Data from a Phase 3 study are expected in Q1 2016.