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发表于 2010-2-4 03:34 PM
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SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq: XNPT - News) announced today that, subject to the approval of the U.S. Food and Drug Administration (FDA), the brand name for GSK1838262/XP13512 (gabapentin enacarbil) in the United States will be Horizant. The Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for Horizant for the treatment of moderate-to-severe primary restless legs syndrome (RLS) is February 9, 2010. Horizant is licensed to GlaxoSmithKline in the United States and several other countries.
Separately, GSK announced today that it is proposing to cease discovery research in certain neuroscience areas, including depression and pain. XP13512 is in development for the management of post-herpetic neuralgia and painful diabetic neuropathy. GSK and XenoPort are discussing the next steps in the development plan for XP13512 in the neuropathic pain area and will disclose this development plan at a future date. |
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