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Pharmaceuticals / Submissions and Approvals

FDA Approves Iroko’s Low-Dose NSAID

Feb. 27, 2014

The FDA has approved Iroko Pharmaceuticals’ Tivorbex, a low-dose painkiller for adult patients, marking the Philadelphia-based drugmaker’s second NDA approval in four months.

Tivorbex (indomethacin), a nonsteroidal anti-inflammatory drug (NSAID), was approved at 20-mg and 40-mg doses for the treatment of mild to moderate acute pain. The product is supported by positive data from two Phase III multi-center, placebo-controlled trials.

The drug contains indomethacin as submicron particles that are approximately 20 times smaller than their original size, the drugmaker says. This provides an increased surface area, leading to faster dissolution, the company adds in touting its proprietary SoluMatrix technology.

The approval nod follows the FDA’s OK of Iroko’s Zorvolex (diclofenac) capsules, developed using the same technology, for the treatment of mild-to-moderate acute pain in adults.

The company’s low-dose pain drugs were developed in reaction to studies showing that serious NSAID adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers and adverse renal events are related to dose. — Johnathan Rickman

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