FDA Lifts Clinical Hold On Flexion Therapeutics's FX006 For Osteoarthritis Pain

December 2, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Flexion Therapeutics, Inc. , a clinical-stage specialty pharmaceutical company, announced on Dec. 1 that the U.S. Food and Drug Administration has lifted its clinical hold on steroid treatment FX006. The injectable, sustained-release, intra-articular steroid treatment is Flexion’s leading drug candidate and is designed for the treatment of moderate to severe osteoarthritis pain in patients.

“We are pleased to have been able to rapidly provide data to the FDA that allowed the agency to remove the clinical hold,” said Michael Clayman, Flexion Therapeutics president and chief executive. “Now we can continue to advance FX006, which has the potential to make a real difference for the many individuals who suffer from OA pain."

The FDA placed a clinical hold on FX006 on Sept. 16 as a result of a single occurrence of infection in the injected knee joint of a patient during a Phase 2b trial. Following the hold, the FDA requested that Flexion Therapeutics determine other potential causes of the infection. The objective was to discover whether the drug was primarily responsible for the infection within the patient.

There have been no other instances of infections within 100 patients dosed with the drug in the same trial. Additionally, the company could not find any indication that sterile procedures were compromised during injections.

The Pain Relief of FX006
Back in June 2013, Flexion Therapeutics initially announced that FX006 could significantly improve the magnitude and duration of pain relief. The optimal dose of FX006 showed that it could be well-tolerated in patients and provide pain relief quickly within the body.

"It's not often we see a pain relief signal in osteoarthritis clinical trials as dramatic as the one seen with FX006," said Matt Provencher, chief of the Sports Medicine Service at Massachusetts General Hospital and Harvard Medical School. "Immediate release steroids are currently front-line intra-articular therapy for patients with degenerative conditions of the knee. With the magnitude and durability of both pain relief and improvement in function seen in this trial, FX006 has the potential to become the new front-line standard-of-care for patients with knee osteoarthritis."

FX006 has demonstrated superior efficacy, and it has maintained therapeutic concentrations in the knee joint significantly longer than TCA IR.