FDA approves Iroko's NSAID for chronic pain

PHILADELPHIA — Pharmaceutical company Iroko announced today that capsules of its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration. This version of the drug is intended to manage pain for those with chronic osteoarthritis. Zorvolex was approved in the United States in October 2013 for the treatment of mild to moderate acute pain in adults.

“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,” said John Vavricka, Iroko’s president and CEO, said. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.” 

In reformulating the drug to manage chronic pain, Iroko followed the FDA’s recommendation that non-steroidal anti-inflammatory drugs contain the minimum effective dose that works for the shortest time. The particles of active ingredient diclofenac are smaller than in normal NSAIDs, but absorption isn’t delayed.

“NSAIDs continue to be an integral part of the management for osteoarthritis, the most common type of arthritis, and their use is likely to increase as the U.S. population continues to age and the incidence of osteoarthritis rises,” said Dr. Roy Altman, a rheumatology professor at the University of California, Los Angeles, said. “The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix NSAID option approved by the FDA for osteoarthritis pain.”

Zorvolex for chronic pain is currently available by prescription.