Flexion Therapeutics announces OA pain injection meets primary endpoint in phase 3 trial

In a phase 3 study, Flexion Therapeutic’s osteoarthritis intra-articular injection for knee pain met its primary endpoint of meaningful pain relief at week 12 compared to placebo, according to a company press release.

The study for Zilretta, also known as FX006, included 486 patients with validated osteoarthritis (OA) at 40 centers internationally. On average, treated patients experienced a 50% reduction in pain from baseline. In addition to its primary endpoint, statistically significant results were observed against triamcinolone acetonide injections in WOMAC A, WOMAC B and WOMAC C scores on secondary measures through week 12.

“There have been no major advances in the treatment of OA for decades and given the limited efficacy and the safety liabilities of available therapies, patients are in need of a new treatment option,” Stan Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at University of Texas Southwestern Medical School, Dallas, said in the release. “These data suggest that Zilretta has the potential to be a significant advance in pain management for patients with OA of the knee.”

The investigational drug is not an opioid and is described by the company as “designed using proprietary microsphere technology intended to provide localized and long-lasting pain relief over a period of months while minimizing systemic exposure and avoiding serious side effects common to oral therapies prescribed for OA pain.”

Reference:

http://flexiontherapeutics.com