Both primary endpoints were met, and XP13512 was well tolerated.
XenoPort reported top-line results from a Phase III evaluation of its restless legs syndrome (RLS) drug. The company’s stock rose about 24% to open the days trading at $35.85.
“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,” says Ronald W. Barrett, Ph.D., CEO of XenoPort. “In addition to the robust efficacy results in this clinical trial, we are happy to see that XP13512 continues to be well tolerated as we expand the number of RLS patients who have been treated with XP13512.”
XP13512 demonstrated statistically significant improvements compared to placebo on both co-primary endpoints and was well tolerated. The endpoints were the change from baseline and the percentage of patients showing significant improvement both at end of treatment. The 12-week, double-blind, placebo-controlled study enrolled 222 patients who were diagnosed with moderate-to-severe primary RLS.
