FDA Approves Extended-Release Intra-Articular Injection

The US Food and Drug Administration recently approved Zilretta, the first and only FDA approved extended-release intra-articular injection osteoarthritis knee pain.

Zilretta is a non-opioid medication that combines the short-acting corticosteroid triamcinolone acetonide with a poly lactic-co-glycolic acid matrix to extend pain relief to over 12 weeks. 
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The approval of Zilretta was based on the results from Flexion’s pivotal phase 3 clinical trial, which included 484 patients at 37 medical centers worldwide. In addition, the results included data on blood glucose concentrations among patients with type 2 diabetes and osteoarthritis knee pain.

Common adverse reactions associated with Zilretta in the clinical trials included sinusitis, cough, and contusions. The safety and efficacy of repeated administration of Zilretta has not been examined.

—Melissa Weiss

Reference:

Flexion Therapeutics announces FDA approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis (OA) knee pain [press release]. Burlington, MA: Flexion Therapeutics Inc., October 6, 2017. http://ir.flexiontherapeutics.com/releasedetail.cfm?ReleaseID=1043084. Accessed October 10, 2017.