Flexion: Clinical Hold Of FX006 Phase 2b Trial In Osteoarthritis Of Knee

(RTTNews) - Flexion Therapeutics Inc (FLXN) said Wednesday the U.S. Food and Drug Administration informed the company 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 of the knee.

Following the announcement, Flexion shares plunged 28 percent in after-hours trade on the Nasdaq.

Flexion said it has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday, 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.

FX006 is a novel, non-opioid, sustained-release, intra-articular formulation of triamcinolone acetonide targeting moderate-to-severe osteoarthritis pain.

Flexion said it will work with FDA to provide the agency with all appropriate information and data required to expedite their review and evaluation of this event. "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."

Flexion stock closed Wednesday at $19.38, down $0.23 or 1.17%, on the Nasdaq. In after hours, the stock dropped $5.43 or 28.02% at $19.38.