Iroko Pharmaceuticals' Zorvolex Approved By FDA For Second Indication
By C. Rajan, contributing writer
Iroko Pharmaceuticals just announced that the U.S. FDA has approved its Zorvolex (diclofenac) capsules, for the management of osteoarthritis pain. This approval marks the second indication for Zorvolex, which already received FDA approval in October 2013 for the treatment of mild to moderate acute pain in adults.
The FDA approval for Zorvolex for the management of osteoarthritis pain was made following review of positive data from a 12-week, multi-center, placebo-controlled clinical trial with 305 patients suffering from osteoarthritis of the hip or knee. Participants were randomized to receive Zorvolex at different doses daily, or a placebo. The Supplemental New Drug Application (sNDA) for Zorvolex also included data from a 12-month open-label safety study that enrolled 602 patients.
Zorvolex is a nonsteroidal, anti-inflammatory drug (NSAID), which was developed to meet FDA recommendations that NSAIDs be used at the lowest effective dose for the shortest possible duration, due to the health risks associated with high-dose and long-term NSAID usage. Zorvolex was approved by the FDA at dosage strengths that are 20 percent lower than currently available diclofenac products.
Zorvolex is also the first FDA-approved low dose NSAID developed using Iroko's proprietary SoluMatrix Fine Particle Technology. Through this technique, the drug molecules are reduced into smaller, submicron particles that are approximately 20 times smaller than their original size. The finer particles encourage faster dissolution of the drug, leading to more efficacy at lower doses.
“Given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, we are delighted to gain approval for our first SoluMatrix NSAID for the management of osteoarthritis pain,” said Dr. Clarence Young, CMO of Iroko Pharmaceuticals. “Iroko has already made great strides to help fill the need for low dose NSAID options in patients with acute pain and we are continuing to expand our portfolio to also address chronic pain indications.”
Iroko is a global specialty pharmaceutical company, which is focused on developing low dose analgesic products. This new indication for Zorvolex marks the third FDA approval for the company in less than a year. In Feb 2014, Iroko Pharmaceuticals received FDA approval for its Tivorbex (Indomethacin) capsules, another NSAID for the treatment of mild to moderate acute pain in adults. Tivorbex was also approved at dosage strengths that are 20 percent lower than the indomethacin products currently on the market for the same indication.
Iroko also has other drugs in the clinical pipeline for treating osteoarthritis pain. In June 2014, Iroko announced the positive Phase 3 results from its Meloxicam low dose NSAID candidate, also developed by the SoluMatrix technology for the treatment of osteoarthritis pain.
Zorvolex is being marketed in the U.S. by Iroko, and does not have marketing rights in other countries. However, Iroko has signed strategic agreements with a few companies to bring Zorvolex to other international markets.