Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has presented phase III results from a study of Zorvolex (diclofenac) capsules in patients with osteoarthritis pain. Taken over a period of twelve weeks, there were no Zorvolex- related serious gastrointestinal, renal or cardiovascular (myocardial infarction or stroke) adverse events, which are all risks associated with nonsteroidal anti-inflammatory drugs (NSAIDs). These data were presented at the 2013 American College of Rheumatology (ACR) Annual Scientific Meeting in San Diego.

Zorvolex is now approved by the US Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults and is under investigation for the treatment of osteoarthritis pain.

Osteoarthritis is one of the most commonly treated conditions in the United States and patients are often treated with NSAIDs to manage their pain for an extended period of time.

“The primary goal of the Iroko clinical development programme is to identify treatment options that potentially address the dose- and duration-related adverse events that accompany traditional NSAIDs,” said Dr Clarence Young, MD, chief medical officer of Iroko Pharmaceuticals. “We are encouraged by these findings as they suggest that Zorvolex may be an effective lower-dose option for the treatment of osteoarthritis pain.”

In a multicentre, double-blind, parallel-group study, 305 patients 41 to 90 years of age with osteoarthritis of the hip or knee were randomized to receive Zorvolex 35 mg three times daily or 35 mg twice daily, or placebo. The primary endpoint was the mean change from baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale at week 12. Safety and tolerability were also assessed. Primary efficacy results were presented earlier this year at the 2013 World Congress on Osteoarthritis, held April 18-21 in Philadelphia.

The most frequently reported adverse events in the study (> 3 percent in any treatment group) were generally similar across treatment groups, and included diarrhea, headache, nausea, and upper respiratory tract infection. No serious gastrointestinal bleeds, cardiovascular (myocardial infarction or stroke) or renal adverse events occurred in any treatment group. The most frequent (= 1 percent in any treatment group) adverse events causing patients to withdraw from the study included diarrhea, upper abdominal pain, and alanine aminotransferase elevation.

The risk of serious adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeds, and renal events such as acute renal failure4 associated with NSAIDs is higher among patients receiving higher doses. Iroko is at the forefront of the development of lower dose NSAIDs—new low dose medicines based on existing NSAIDs—using iCeutica Pty Ltd’s proprietary SoluMatrix Fine Particle Technology exclusively licensed to Iroko for use in NSAIDs.

Zorvolex was approved by the US Food and Drug Administration (FDA) in October 2013 for the treatment of mild to moderate acute pain in adults1. It is the first and only FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology. 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.

Iroko develops and globally commercializes pharmaceutical products.