XenoPort Reports Positive Top-Line Phase 3 Trial Results of XP13512 in Restless Legs Syndrome
On April 25th of 2007, the biopharmaceutical company ?XenoPort, Inc?, based in Santa Clara CA, announced top-line results from a Phase 3 clinical trial of XP13512 for the treatment of symptoms of primary restless legs syndrome (RLS). XP13512 demonstrated statistically significant improvements compared to placebo on both of the co-primary endpoints of the trial and was well tolerated.
This XenoPort study was a 12-week, double-blind, placebo-controlled Phase 3 clinical trial that enrolled 222 patients who were diagnosed with moderate-to-severe primary RLS. Patients were treated with either 1200 mg of XP13512 or placebo, given once per day. Treatment with 1200 mg of XP13512 was associated with a statistically significant improvement compared to placebo. At the end of treatment, significantly more patients treated with XP13512 were reported as ?much improved? or ?very much improved? compared to those treated with placebo (76% vs. 39%).
During treatment over the 12-week period, the most commonly reported adverse events for XP13512 versus placebo were somnolence (26.5% XP13512; 7.4% placebo) and dizziness (19.5% XP13512; 4.6% placebo). There were no reported serious adverse events in XP13512-treated patients.
XP13512 works by a different mechanism than currently approved RLS drugs, and therefore may offer an alternative treatment option for patients whose lives are disrupted by RLS symptoms. In addition to the robust efficacy results in this clinical trial, XP13512 continues to be well tolerated as we expand the number of RLS patients who have been treated with XP13512.
XP13512 is a patented, new chemical entity that is designed to improve upon the clinical utility of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.
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