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Iroko granted FDA approval for new osteoarthritis therapy

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Iroko Pharmaceuticals announced recently that Zorvolex, the company’s new NSAID for the management of osteoarthritis pain, has received approval from the U.S. Food and Drug Administration.

Previously approved by the FDA in October 2013 for mild-to-moderate acute pain relief in adults, Zorvolex (diclofenac) contains submicron particles of diclofenac 20 times smaller than their original size, leading to faster dissolution of the drug. The NSAID was designed to be used at low doses for short durations, consistent with FDA and other organizational guidelines, according to a company press release.

“Expanding the use of Zorvolex beyond acute pain to osteoarthritis pain, a chronic condition, is a testament to Iroko’s continued commitment to developing a low-dose NSAID portfolio to address a broad range of unmet patient needs,” John Vavricka, president and CEO of Iroko Pharmaceuticals, said in the press release. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”