FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. FDA approval of ZORVOLEX was supported by data from a Phase 3 multi-center, randomized study in which patients treated with ZORVOLEX reported significant pain relief compared with patients receiving placebo.

"The approval of ZORVOLEX is important news for patients and for physicians who need new options for effective pain relief, and is a significant milestone for Iroko," said John Vavricka, President and CEO of Iroko Pharmaceuticals. "This marks a major achievement towards our goal of applying new technology to existing NSAIDs in order to address unmet medical needs in analgesia."

ZORVOLEX was developed to address FDA's public health advisory recommending that NSAIDs be used at the lowest effective dose for the shortest duration of time 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.

"Given the serious, dose-related safety concerns associated with traditional NSAIDs, there is a need for new NSAID treatment options that can provide acute pain relief with lower systemic exposure," said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. "By altering the absorption properties of diclofenac using innovative technology, ZORVOLEX offers patients the prospect of pain relief at lower doses."

ZORVOLEX is the first and only NSAID developed using proprietary SoluMatrix Fine Particle Technology™.

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.

"Whenever I prescribe any pain medication to my patients I am concerned about two things - how effective the medication will be and the adverse event profile. Thus, ZORVOLEX is a welcome new therapeutic option," said Allan Gibofsky, Professor of Medicine and Public Health at Weill Medical College of Cornell University.

"The approval of ZORVOLEX is extremely rewarding, and is the result of our hard work and dedication within Iroko to make a lower dose diclofenac available to patients and physicians," said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals. "We look forward to progressing the rest of our lower dose NSAID portfolio."