FDA Approves Submicron NSAID for Osteoarthritis

The US Food and Drug Administration has approved Zorvolex, a submicron formulation of diclofenac, for the treatment of pain due to osteoarthritis (OA).

Distributed by Iroko Pharmaceuticals, Zorvolex had already been approved for treatment of mild to moderate pain. The submicron formulation was created to reduce the likelihood of adverse events common to non-steroidal anti-inflammatory drugs (NSAIDs).

At the May meeting of the Osteoarthritis Research Society International in Paris, rheumatologist Vibeke Strand of Stanford University and others reported on a randomized placebo-controlled trial of the drug in 305 patients with OA. Those taking the drug twice or three times daily experienced significant improvements in pain subscales over those on placebo.

The most common adverse events were mild gastrointestinal symptoms.