HorizantTreatment for Restless Legs Syndrome, Postherpetic Neuralgia
Horizant (gabapentin enacarbil) Now Approved - April 6, 2011
XenoPort Announces Horizant as Brand Name for XP13512
XenoPort Announces Horizant as Brand Name for XP13512
SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. 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.
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate, XP13512, in collaboration with Astellas Pharma Inc. and GSK. The FDA is currently reviewing GSK's NDA for Horizant as a potential treatment for RLS in the United States. The Pharmaceuticals and Medical Device Agency is currently reviewing Astellas' NDA for XP13512 as a potential treatment for restless legs syndrome in Japan. XenoPort's product candidates are being studied for the potential treatment of RLS, gastroesophageal reflux disease, migraine headaches, neuropathic pain, spasticity and Parkinson's disease.
This press release contains "forward-looking" statements, including, without limitation, all statements related to XenoPort's and its partners' future clinical development and commercialization of XP13512 and the timing thereof; the therapeutic and commercial potential of XP13512; the suitability of XP13512 as a treatment for RLS, neuropathic pain and prevention of migraine headaches; U.S. and Japanese regulatory processes and the timing thereof; and XenoPort's and its partners' future clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "plan" and "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the uncertain results and timing of clinical trials; XenoPort's or its partners' ability to successfully conduct clinical trials in the anticipated timeframes, or at all; risks related to the uncertainty of the FDA approval process, the Japanese NDA filing process and other regulatory requirements; XenoPort's dependence on its current and additional collaborative partners; and the uncertain therapeutic and commercial value of XenoPort's product candidates. These and other risk factors are discussed under the heading "Risk Factors" in XenoPort's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2009. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
XenoPort is a registered trademark of XenoPort, Inc.
Posted: February 2010
- GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia - June 7, 2012
- GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant - April 6, 2011
- GlaxoSmithKline and XenoPort Respond to FDA on Horizant for RLS - November 8, 2010
- Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter - February 19, 2010
- GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS - February 18, 2010
- XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010 - February 10, 2010
- XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA - March 16, 2009
- GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome - January 9, 2009
- GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome - November 10, 2008
- GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome - September 16, 2008
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