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.
Get the full story at our sister site, Drug Delivery Business News.
The post Flexion seeks FDA nod for osteoarthritis steroid injection appeared first on MassDevice.
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