FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Application (sNDA) for ZORVOLEX™ (diclofenac), a lower dose nonsteroidal anti-inflammatory drug (NSAID), for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults.

"FDA's acceptance of our sNDA filing for ZORVOLEX provides further momentum toward our goal of identifying lower dose treatment options that potentially address the dose-related serious adverse events that accompany traditional NSAIDs," said John Vavricka, President and CEO of Iroko Pharmaceuticals. "Minimizing the risk of these serious treatment-related adverse events is particularly important in chronic conditions like osteoarthritis where patients may require long-term NSAID treatment to manage their pain."

ZORVOLEX was developed to address FDA's public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The risk of serious adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds and renal events such as acute renal failure associated with NSAIDs is higher among patients receiving higher doses.

The sNDA for ZORVOLEX in the treatment of osteoarthritis pain included 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. Participants were randomized to ZORVOLEX 35mg three times daily or 35mg twice daily, or placebo⁶. Data from this study were presented at the World Congress on Osteoarthritis in April 2013. The sNDA also included data from a 12-month open-label study that enrolled more than 600 patients.