FDA approves NSAID to address dose-related safety concerns

FDA has approved diclofenac (Zorvolex, Iroko Pharmaceuticals) 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% lower than currently available diclofenac products.

The approval was supported by data from a phase 3 multicenter, randomized study in which patients treated with diclofenac reported significant pain relief compared with patients receiving placebo.

Every year in the United States there are 70 million physician visits due to pain, and approximately 109 million NSAID prescriptions are written.

Zorvolex was developed to align with public health recommendations from FDA and professional medical organizations including the American Heart Association, American Gastroenterological Association, and the American College of Rheumatology, that NSAIDs be used at the lowest effective dose for the shortest possible duration of time consistent with individual patient treatment goals, according to Clarence L. Young, MD, senior vice president and chief medical officer, Iroko Pharmaceuticals. 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 of NSAIDs.

“As serious adverse events with currently marketed NSAIDs have been demonstrated to be dose-related, a significant unmet need exists for new products that can provide effective pain relief at low doses,” Dr Young told Formulary. “Additionally [Zorvolex], provides prescribers with an effective non-opioid alternative for pain management.”

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.