Key Developments For XenoPort, Inc.
XenoPort, Inc. (XNPT.O) (Nasdaq)
Astellas Pharma Inc. and XenoPort, Inc Announces Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome
Astellas Pharma Inc. and XenoPort, Inc. announced a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The data supporting safety and efficacy in the NDA filing comes from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan and the RLS clinical program conducted by XenoPort in the United States. The acceptance of filing of the NDA triggers a $5 million payment from Astellas to XenoPort.
XenoPort, Inc. and GlaxoSmithKline plc Says FDA Review Of Neuropathic Pain Drug Extended 3 Months, To February 2010-AP
The Associated Press reported that the Food and Drug Administration needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline plc, the companies said. XenoPort and GlaxoSmithKline said the FDA should complete its review of the drug, called gabapentin enacarbil, by February 9, 2010. The review period was scheduled to end November 9, 2009. The FDA wanted the companies to develop a strategy to evaluate the drug's risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.
XenoPort, Inc. Announces Initiation Of A Phase 2b Clinical Trial Of Arbaclofen Placarbil In Patients With Gastroesophageal Reflux Disease
XenoPort, Inc. announced that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs. XenoPort expects to enroll approximately 425 subjects in this trial, which is being conducted in the United States and Canada. Subjects with a history of incomplete response to a PPI will undergo a four-week run-in on PPI therapy followed by a six-week treatment period on PPI therapy plus either 20 mg or 40 mg of AP dosed once daily, 20 mg or 30 mg of AP dosed twice daily or placebo. The primary endpoint of the study will examine heartburn events. Regurgitation will be assessed as a key secondary endpoint.
GlaxoSmithKline plc And XenoPort, Inc. Announces Positive Phase II Results For GSK1838262
GlaxoSmithKline plc and XenoPort, Inc. announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher. In this double-blind, two-period cross-over study, 3600 mg/day of GSK1838262 demonstrated a statistically significant improvement over 1200 mg/day of GSK1838262 on the primary endpoint, which was the change from baseline to the end of the treatment period in the 24-hour average pain intensity score. A greater reduction in the 24-hour average pain score was observed for the 3600 mg/day dose than for the 1200 mg/day dose (adjusted difference of -0.29; p=0.013). This study enrolled 138 subjects diagnosed with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. Subjects with a history of inadequate response to gabapentin entered a baseline period where they received a dose of 1800 mg/day of gabapentin for two weeks. Subjects (N=96) who had a 24-hour average pain score of at least four on the 11-point pain intensity rating scale were then randomized to receive either 1200 mg/day of GSK1838262 for the first 28-day treatment period followed by 3600 mg/day for the second 28-day treatment period, or 3600 mg/day followed by 1200 mg/day.
GlaxoSmithKline plc And XenoPort, Inc. Announces Positive Phase IIb Results For GSK1838262 (XP13512)
GlaxoSmithKline plc and XenoPort, Inc. announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults. In this study, subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of GSK1838262 dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score. This 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. The pre-specified statistical analysis included adjustment for comparisons of multiple GSK1838262 doses to placebo. The adjusted p-values for comparison of 1200, 2400 and 3600 mg/day doses to placebo were 0.013, 0.029 and 0.002, respectively. GSK1838262 was generally well tolerated at all doses in this study. The most common adverse events were dizziness (placebo 15%, 1200 mg/day 17%, 2400 mg/day 26% and 3600 mg/day 30%) and somnolence (8%, 10%, 11% and 14%, respectively). Most of these adverse events were mild or moderate in intensity. Withdrawals due to adverse events were 13%, 6%, 15% and 18%, respectively.
