Flexion Therapeutics (NSDQ:FLXN) said today that it submitted a new drug application to the FDA for its extended-release steroid injection Zilretta. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection last year.
The new drug application is based on data from a pivotal phase III clinical trial evaluating Zilretta in patients with moderate to severe osteoarthritis knee pain. The randomized, double-blind study enrolled 484 patients at 37 centers to compare the injection to a placebo and a commonly injected intra-articular corticosteroid. In both comparisons, patients who were treated with Zilretta had a statistically significant reduction in average daily pain after 12 weeks. No drug-related serious adverse events were reported.
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