FDA approves Zorvolex for Osteoarthritis Pain - Iroko Pharma

The FDA has approved Zorvolex (diclofenac low dose) capsules, from Iroko Pharmaceuticals, for the management of Osteoarthritis Pain. This marks the second indication for the drug which was approved by FDA in October 2013 for the treatment of mild to moderate acute Pain in adults. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.

The approval 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 placebo. The Supplemental New Drug Application (sNDA) also included data from a 12-month open-label safety study that enrolled 602 patients.