ARTICLE | Company News

Flexion discusses sterility issue

September 19, 2014 2:44 AM UTC

On a conference call with investors to discuss a clinical hold on FX006, Flexion Therapeutics Inc. (NASDAQ:FLXN) ) said one of FDA's "central concerns" relates to the administered product's sterility; however, the company has "high confidence" that the product is sterile.

Flexion executives said the company plans to submit evidence of sterility to remove the hold and resume the trial, which was halted after one patient developed an infection in a knee joint after an injection of FX006, which is in Phase IIb development for osteoarthritis knee pain. ...