FDA Approves Another Lower-Dose NSAID

Pauline Anderson

February 25, 2014

The US Food and Drug Administration (FDA) has approved indomethacin capsules (Tivorbex, Iroko Pharmaceuticals LLC) at 20-mg and 40-mg doses for the treatment of mild to moderate acute pain in adults.

These dosages of the nonsteroidal anti-inflammatory drug (NSAID) are 20% lower in strength than the 25-mg and 50-mg indomethacin products already on the market, a company press release notes.

The approval "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, in the release.

"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," added Roy D. Altman, MD, professor of medicine, rheumatology, University of California at Los Angeles.

The FDA approval was supported by data from 2 phase 3 multicenter, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with postsurgical acute pain receiving the drug compared with those taking placebo.

Tivorbex is Iroko's second approved lower-dose NSAID. In October 2013, the FDA approved the company's diclofenac capsules (Zorvolex) for the treatment of mild to moderate acute pain in adults.

Reduced Particle Size

Both drugs use proprietary SoluMatrix Fine Particle Technology and contain 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, according to the company's press release.

While indomethacin and other NSAIDs have potent anti-inflammatory and analgesic properties, research has linked these drugs to sometimes serious adverse outcomes, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers, gastrointestinal bleeding, and renal events (such as acute renal failure). 

The FDA and professional medical organizations, including the American Heart Association, American Gastroenterological Association, and the American College of Rheumatology, therefore recommend that NSAIDs be used at the lowest effective dose for the shortest possible duration of time consistent with individual patient treatment goals, the release adds.


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