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Pharmaceuticals / Submissions and Approvals

Zorvolex Approved by FDA for New Indication

Sept. 3, 2014

Iroko Pharmaceuticals’ low-dose painkiller Zorvolex is now available for patients with osteoarthritis pain, following FDA’s approval for the second indication.

The agency decision was based on a randomized, placebo-controlled trial of 305 patients with osteoarthritis of the hip or knee, and on a year-long open-label safety study of 602 patients. This is the first approval of a non-steroidal anti-inflammatory drugs (NSAIDs) made using Iroko’s particle technology that shrinks diclofenac — the drug’s main ingredient — down by a factor of 20, which leads to faster dissolution, the company said Tuesday.

The approval is consistent with recent FDA recommendations that NSAIDs be used at the lowest possible dose for the shortest possible duration, Iroko said.

The same drug class garnered worry in the last year, with the FDA issuing an advisory that several types of the drug were associated with increased risk of heart attack and stroke. An FDA advisory panel in February recommended general changes to NSAIDs’ labeling to reflect a short-term risk of such events.

Zorvolex originally received approval to treat mild to moderate to acute pain for adults in October 2013. The company has completed multiple studies on diclofenac, as well as two other painkillers, with a Phase III trial of meloxicam capsules ongoing. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.