The US Food and Drug Administration (FDA) is to review Iroko Pharmaceuticals’ supplemental new drug application (sNDA) for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug (NSAID) for treating osteoarthritis pain in adults.
In October 2013, FDA approved ZORVOLEX for the treatment of mild to moderate acute pain in adults.
Iroko Pharmaceuticals president and CEO John Vavricka said FDA’s acceptance of the company’s sNDA filing for ZORVOLEX helps its goal of identifying lower dose treatment options that potentially address the dose-related serious adverse events that accompany traditional NSAIDs.
"Minimising 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," Vavricka said.
The company said that Zorvolex was developed to align with FDA’s public health advisory recommending that NSAIDs should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Patients who receive higher doses will have higher 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.
The sNDA for ZORVOLEX included data from a 12-week, multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee.
In the trial, participants were given ZORVOLEX 35mg three times daily or 35mg twice daily, or placebo.
The company said that the sNDA also included data from a 12-month open-label study that enrolled more than 600 patients.
Zorvolex is the first lower dose FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology and it contains diclofenac as submicron particles that are about 20 times smaller than their original size.
Image: Osteoarthritis of the left knee. Photo: courtesy of OgreBot.