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FDA accepts Horizant response

November 5, 2010 11:19 PM UTC

FDA accepted for review a response from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to a February complete response letter for Horizant gabapentin enacarbil ( XP13512, GSK1838262) extended-release tablets to treat moderate to severe primary restless legs syndrome (RLS). FDA designated the response as a Class 2 resubmission and set a PDUFA date of April 6, 2011.

GSK and partner XenoPort Inc. (NASDAQ:XNPT) said the submission included updated safety data and new data from nonclinical studies of the transported prodrug of gabapentin, as well as two epidemiology studies exploring gabapentin use and cancer. GSK also amended the NDA to be under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...