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news.Emerging biopharm company AlphaRx has been given the go-ahead by Canadian health authorities to initiate a phase II human trial of its lead product Indaflex as a treatment for osteoarthritis.
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The study is designed to evaluate the safety and efficacy of 2.5% Indomethacin cream, Indaflex. A total of 210 patients with osteoarthritis of the knee will be randomly divided into three groups to receive Indaflex, placebo-vehicle or placebo over a period of 6 weeks.
AlphaRx reports that Indaflex has demonstrated an excellent safety and efficacy profile in preclinical studies and has recently completed a phase I clinical trial indicating minimum systemic exposure of drug after topical application of Indaflex, further supporting the drug’s systemic safety profile.
Indaflex is approved for sale by prescription in Mexico for the treatment of various inflammatory conditions including osteoarthritis. Currently, no prescription strength topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of arthritis is approved for sale in the US.