Reuters: Regulatory News: U.S. health regulator approves Iroko's pain drug

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U.S. health regulator approves Iroko's pain drug Oct 18th 2013, 22:48 Fri Oct 18, 2013 6:48pm EDT Oct 18 (Reuters) - Privately held Iroko Pharmaceuticals Inc said the U.S. Food and Drug Administration approved its capsules to treat mild to moderate acute pain in adults. The drug, Zorvolex, is approved at a dosage strength that is 20 percent lower than currently available treatments, the company said in a statement. The current available treatments have higher dosages increasing the risk of serious adverse events including strokes, gastrointestinal ulcers and acute renal failures, the company said. The drug comes under the category of nonsteroidal anti-inflammatory drugs (NSAID), which are medicines that relieve pain including swelling, stiffness and inflammation. A late-stage study of the drug showed that patients showed significant pain relief compared with patients on a placebo. Iroko had filed for an initial public offering of $145 million in June 2013 but withdrew its plans, saying that the timing of the offering might not be in its best interests.

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