ARTICLE | Clinical News

FX006: Phase II hold

September 22, 2014 7:00 AM UTC

Flexion said FDA placed a clinical hold on a double-blind, placebo-controlled, U.S. Phase IIb trial of FX006 following an infection in 1 patient's knee joint after FX006 was injected in the joint. On a conference call with investors, Flexion 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. The company plans to submit evidence of sterility to remove the hold and resume the trial. Flexion said the company will investigate the vials used to treat the patient, the trial site and the patient's medical records. The company noted that about 300 patients have been treated with FX006 without any infections. ...