By Emily Delzell
The US Food and Drug Administration (FDA) in August approved Iroko Pharmaceuticals’ low-dose nonsteroidal anti-inflammatory drug (NSAID) for management of osteoarthritis pain.
Zorvolex (diclofenac), which has dosage strengths that are 20% lower than currently available diclofenac products, was developed to align with FDA and other medical organization recommendations that NSAIDs be used at the lowest effective dose, according to the Philadelphia, PA-based pharmaceutical company.
The approval was based on results from a phase 3 multicenter randomized controlled trial of 305 patients with knee or hip osteoarthritis, which showed 35 mg of Zorvolex taken three time a day significantly reduced pain at 12 weeks from baseline compared with placebo. Data were presented at the 2013 American College of Rheumatology Annual Scientific Meeting in San Diego.
This is second indication for Zorvolex, which the FDA approved in October 2013 for treatment of mild to moderate acute pain.