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news.Ontario-based AlphaRx Inc has received approval from the appropriate authorities to begin a phase I human trial for arthritis treatment Indaflex, the company's lead pharmaceutical product.
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The primary objective of this study is to evaluate the safety and tolerability of single- and multiple-dose applications of Indaflex, a novel formulation of indomethacin cream. The secondary objective of this study will be to evaluate the bioavailability of Indaflex relative to Indomethacin 50mg capsules, after a single-dose in healthy subjects.
Indaflex is AlphaRx’s topical non-steroidal anti-inflammatory drug (NSAID) formulation intended to start clinical development soon in treating symptoms of arthritis. Indaflex’s active ingredient, Indomethacin, has long-standing and proven clinical treatment records and is the active ingredient in Merck & Co’s Indocin products.
With AlphaRx’s enhanced proprietary delivery system, the company believes the drug’s clinical effectiveness will be significantly enhanced compared to other topical preparations. Topical Indaflex delivery, the company hopes, may circumvent the significant GI side-effects found with orally ingested NSAIDs.