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news.The US Food and Drug Administration (FDA) has approved Iroko Pharmaceuticals' Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.
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In October 2013, Zorvolex was approved by the FDA to treat mild to moderate acute pain in adults.
The prescription-based Zorvolex is the first FDA-approved low dose NSAID developed using SoluMatrix Fine Particle Technology.
The drug contains diclofenac as submicron particles that are developed about 20 times smaller than their original size to offer increased surface area and faster dissolution.
Iroko Pharmaceuticals chief medical officer Dr Clarence Young said given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, the company is happy to secure approval for its first SoluMatrix NSAID for the management of osteoarthritis pain.
"Iroko has already made great strides to help fill the need for low dose NSAID options in patients with acute pain and we are continuing to expand our portfolio to also address chronic pain indications," Young said.
The FDA approval was based on data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial, which enrolled 305 patients with osteoarthritis of the hip or knee, aged between 41 to 90 years.
During the trial, patients were randomized to Zorvolex 35mg three times daily or 35mg twice daily, or placebo.