HorizantTreatment for Restless Legs Syndrome, Postherpetic Neuralgia
Horizant (gabapentin enacarbil) Now Approved - April 6, 2011
Complete Response Letter for Horizant
GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 18, 2010 - GlaxoSmithKline and XenoPort, Inc. (Nasdaq:XNPT) Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant (gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).
A Complete Response letter is issued by the FDA's Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. GSK and XenoPort are currently evaluating the Complete Response letter, in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time. FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks. The companies are assessing the appropriate next steps and will be communicating with FDA.
The NDA was submitted to the FDA on January 9, 2009.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
XenoPort 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. Gabapentin enacarbil is also being developed in partnership with Astellas Pharma Inc. for the potential treatment of Restless Legs Syndrome in Japan. XenoPort's product candidates are being evaluated as potential treatments for patients with neuropathic pain, migraine (as prophylactic treatment), gastroesophageal reflux disease, spasticity and Parkinson's disease.
Horizant was formerly referred to by the proposed trade name Solzira.
GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.
XenoPort Forward-Looking Statement
This press release contains "forward-looking" statements, including, without limitation, all statements related to the therapeutic and commercial potential of XenoPort's product candidates and potential future interactions with the FDA related to the NDA for Horizant for the treatment of RLS. 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 "potential," “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 ability of the company to successfully conduct clinical trials of its product candidates, and the results thereof; the uncertainty of the FDA approval process and other regulatory requirements; XenoPort's dependence on its current and additional collaborative partners; and the therapeutic and commercial value of the company's compounds. These and other risk factors are discussed under the heading "Risk Factors" in XenoPort's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, 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.
Horizant is a trademark of GSK. XenoPort is a 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
- XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010 - February 10, 2010
- XenoPort Announces Horizant as Brand Name for XP13512 - February 4, 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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