FDA approves Flexion Therapeutics' osteoarthritis knee pain drug — 4 insights

The FDA approved Flexion Therapeutics' Zilretta, an intra-articular therapy for osteoarthritis knee pain.

Here's what you should know:

1. Flexion is marketing the drug as the first and only extended-release intra-articular injection for osteoarthritis knee pain.

2. The drug provides pain relief for 12-plus weeks.

3. The FDA based its approval on Flexion's phase III clinical trial. The trial enrolled 484 patients at 37 centers worldwide.

4. Flexion expects Zilretta will be available in the U.S. by the end of October.

Los Angeles-based Cedars-Sinai Orthopaedic Center's Joint Replacement Program Co-Director Andrew Spitzer, MD, said in a release, "Zilretta is a groundbreaking new therapy, providing clinically meaningful pain relief with a safety profile that is similar to saline."

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