FDA Approves Treatment for Osteoarthritis

The FDA approved diclofenac capsules (Zorvolex^™) for the management of osteoarthritis pain.

This is the second indication for diclofenac, which was first approved by the FDA in October 2013 for mild-to-moderate acute pain in adults.

The recommended doses are 18 mg or 35 mg taken 3 times daily for acute pain and 35 mg taken 3 times daily for osteoarthritis pain.

This is the first FDA-approved low-dose nonsteroidal anti-inflammatory drug developed by using proprietary SoluMatrix Fine Particle Technology, according Iroko Pharmaceuticals, the manufacturer, in a news release.

The drug contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution, according to the manufacturer.

Diclofenac was specifically designed to address recommendations from the FDA and several medical groups that NSAIDs should be used at the lowest effective dose for the shortest possible duration, the company says.

The approval for osteoarthritis pain was supported by data from a 12-week, multicenter, randomized, controlled trial in 305 adults with osteoarthritis of the hip or knee, in which participants took diclofenac 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.—Kerri Fitzgerald