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FDA Okays Lower-Dose NSAID, Tivorbex, for Acute Pain in Adults

Capsules contain submicron particles of indomethacin (February 24)

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% lower than the 25-mg and 50-mg indomethacin products currently on the market.

The FDA’s approval was based on data from two phase III placebo-controlled trials, which demonstrated significant improvements in pain relief in patients with postsurgical acute pain who were treated with Tivorbex compared with patients receiving placebo.

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, according to the product’s manufacturer (Iroko Pharmaceuticals).

In October 2013, the 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 in the U.S.

Source: Iroko Pharmaceuticals; February 24, 2014.

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