Iroko Pharmaceuticals Receives FDA Approval for TIVORBEX™

Tue, 02/25/2014 - 8:31am

Iroko Pharmaceuticals, LLC, has announced that the FDA has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.

TIVORBEX was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market 2. FDA approval of TIVORBEX was supported by data from two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving TIVORBEX compared with patients receiving placebo 3.

“The FDA approval of TIVORBEX is another significant milestone for Iroko as it validates our strategic approach towards developing a suite of NSAID products that offer pain management at lower doses,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.”

TIVORBEX contains indomethacin 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. In October 2013, FDA approved Iroko’s ZORVOLEX™ (diclofenac) capsules, also developed using this technology, for the treatment of mild to moderate acute pain in adults. ZORVOLEX is now available at pharmacies in the U.S. 4

“Based on recommendations from FDA and other professional organizations, physicians look for the lowest dose option that will provide the appropriate amount of relief for patients experiencing acute pain. I’m excited to see that Iroko is continuing to develop additional lower dose NSAIDs as potential treatment options for my patients,” said Roy D. Altman, M.D., Professor of Medicine, Rheumatology at the University of California at Los Angeles.



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