The US Food and Drug Administration (FDA) has approved diclofenac capsules (Zorvolex, Iroko Pharmaceuticals) for the management of osteoarthritis (OA) pain, the company announced today.
OA pain is the second indication for Zorvolex, first approved by the FDA in October 2013 for mild-to-moderate acute pain in adults, as reported by Medscape Medical News.
Zorvolex is the first FDA-approved low-dose nonsteroidal anti-inflammatory drug (NSAID) developed by using proprietary SoluMatrix Fine Particle Technology, the company notes in a news release.
The approval of Zorvolex for OA pain was supported by data from a 12-week, multicenter, randomized controlled trial in 305 adults with OA of the hip or knee in which participants took Zorvolex 35 mg 2 or 3 times daily or placebo. The Supplemental New Drug Application also included data from a 12-month open-label safety study that enrolled 602 patients.
NSAIDs continue to be “an integral part” of the management for OA, the most common type of arthritis, and their use is likely to increase as the US population continues to age and the incidence of OA increases, Roy Altman, MD, professor of medicine in rheumatology at University of California Los Angles. Reviewed/posted by Dr. Russell