Burlington, Mass.-based Flexion Therapeutics submitted a new drug application to the FDA for Zilretta.
Here's what you need to know.
1. Zilretta is a intra-articular injection which can treat patients with osteoarthritis of the knee.
2. The FDA awarded Zilretta a fast track designation.
3. Flexion submitted Zilretta as a 505(b)(2) application. The FDA has up to 74 days to inform Flexion if the submission was complete and if it permits a full review.
4. Flexion recently completed a phase III clinical trial. In the randomized, double blind, placebo and active-comparator controlled trial, Zilretta highly reduced average daily pain versus a placebo.
The most common adverse event associated with Zilretta at an incidence greater than 2 percent was arthralgia, headaches, joint swelling and back pain. There were no serious adverse events observed and none of the 484 patients in the study discontinued treatments.
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