ARTICLE | Clinical News

FDA lifts clinical hold on Flexion's FX006

December 2, 2014 3:36 AM UTC

Flexion Therapeutics Inc. (NASDAQ:FLXN) said Monday that FDA lifted a clinical hold on FX006 to treat osteoarthritis (OA) knee pain. The company intends to immediately resume a pivotal Phase IIb trial and begin a Phase III trial early next year.

The agency placed the hold in September. Flexion said one patient treated with FX006 was initially believed to have developed septic arthritis of the knee, but a principal investigator later changed the diagnosis to inflammatory arthritis unrelated to treatment in the study (see BioCentury Extra, Sept. 18). ...