GlaxoSmithKline and XenoPort respond to FDA on Horizant for RLS; Pozen gets positive advisory recommendation on GI drug
UK pharma giant GlaxoSmithKline (LSE: GSK) and partner XenoPort (Nasdaq: XNPT) said on Friday that the US Food and Drug Administration has accepted for review GSK’s response to the agency’s Complete Response letter for Horizant (gabapentin enacarbil) extended-release tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Earlier this year, the FDA issued a negative response to the Horizant New Drug Application indicating that a preclinical finding of pancreatic canard cell tumours in rats was of sufficient concern to preclude approval of Horizant for RLS at that time (The Pharma Letter February 18).
FDA has designated the latest resubmission as a Class 2 response and set a new Prescription Drug User Fee Act goal date of April 6, 2011, the companies noted.
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