Flexion Therapeutics Announces Clinical Hold Of FX006 Phase 2B Clinical Trial In Osteoarthritis Of The Knee

Flexion Therapeutics, Inc.

today announced that the United States Food and Drug Administration (FDA) informed the company yesterday that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2b clinical trial evaluating FX006 in patients with osteoarthritis (OA) of the knee. FX006 is a novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA) targeting moderate-to-severe OA pain. Flexion has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to a single occurrence of an infection in the injected knee joint of a patient in the Phase 2b clinical trial. "We will work closely with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation of this event," said Michael Clayman, M.D., President and CEO of Flexion. "Once the FDA has completed its review, we can better assess the impact this clinical hold will have on our development program timeline for FX006."