Flexion's Zilretta receives FDA approval
Flexion Therapeutics announced that the U.S. Food and Drug Administration approved Zilretta, the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta is a non-opioid medicine that employs Flexion's proprietary microsphere technology to provide proven pain relief over 12 weeks. "The approval of Zilretta marks a major advancement in the treatment landscape for managing OA knee pain," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. "It comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition." Dr. Clayman added, "We believe that Zilretta has the potential to be a transformative medicine for the more than five million patients who receive an intra-articular injection for OA knee pain each year." The FDA approval of Zilretta is based upon data from Flexion's pivotal Phase 3 clinical trial. The randomized, double-blind study enrolled 484 patients at 37 centers worldwide.