Burlington, MA-based Flexion Therapeutics reported on September 1 that the US Food and Drug Administration (FDA) has granted Fast Track designation for FX006, Flexion’s late-stage lead drug candidate for osteoarthritis (OA) of the knee.
FX006 is a potential first-in-class injectable, sustained-release, intra-articular drug for patients with moderate to severe knee OA pain. It provides long-lasting local analgesia while avoiding systemic side effects, according to Flexion.
About 600 patients have been treated with FX006. In a completed phase 2b dose-ranging clinical trial, FX006 has demonstrated clinically meaningful and significantly improved pain relief compared with the current injectable standard of care, triamcinolone acetonide. In two phase 2a synovial fluid pharmacokinetic studies, a single injection of FX006 demonstrated therapeutic concentrations of the drug in joint fluid for at least 12 weeks. Data from a phase 3 clinical trial are expected in the first quarter of 2016.