Iroko Pharmaceuticals LLC announced that the FDA has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. This marks the second indication for ZORVOLEX, approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.
“Given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, we are delighted to gain approval for our first SoluMatrix NSAID for the management of osteoarthritis pain,” said Dr. Clarence chief medical officer of Iroko Pharmaceuticals. “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.”
“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, president and CEO of Iroko Pharmaceuticals. “This second approval for ZORVOLEX continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”
According to a press release, the approval of ZORVOLEX for the management of osteoarthritis pain was supported by data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee. Half of the patients were between the ages of 61-90. Participants were randomized to ZORVOLEX 35mg three times daily or 35mg twice daily, or placebo3. The Supplemental New Drug Application (sNDA) also included data from a 12-month open-label safety study that enrolled 602 patients. Read the full press release