XenoPort, Glaxo report positive Phase III RLS drug study

Published by cafead January 15th, 2008 in biotech, big pharma
http://www.cafepharma.com/detailpiece/0759

XenoPort, Inc. (Nasdaq:XNPT) and GlaxoSmithKline (NYSE:GSK) today announced positive top-line results from a Phase 3 clinical trial designed to evaluate the potential of XP13512 (GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome, (RLS). The study showed that XP13512 was generally well tolerated and that there was a statistically significant difference between patients treated with XP13512 and placebo who met study met study inclusion criteria.

The CEO of Xenoport said, “The results of this study strengthen our belief that XP13512 has the potential to be a safe and effective treatment for primary RLS. Our first placebo-controlled Phase 3 efficacy trial of XP13512, with results announced in April 2007, demonstrated statistically significant benefits of XP13512 in treating RLS symptoms over 12 weeks. We are encouraged by the results of this new placebo-controlled Phase 3 clinical trial, which demonstrated that XP13512 was effective and generally well-tolerated when administered to primary RLS patients for nine months,”

XP13512 is a patented, new chemical entity that is designed to improve the clinical utility of gabapentin by utilizing high-capacity transport mechanisms in the gastrointestinal tract to improve absorption. Currently, doses of gabapentin greater than 1,200mg are poorly absorbed due to transport mechanisms in the gut being overloaded. This new technology may show promise in achieving higher blood levels of gabapentin for RLS and many other conditions in which gabapentin is used frequently (i.e. psychiatry, pain, headaches).

RLS affects up to 12 million people in the U.S. according to the National Institutes of Health. RLS is characterized by unpleasant and sometimes painful sensations in the legs hat result in a compelling urge to move. Data suggests that RLS can have an impact on quality of life that is equal to or worse than major chronic disorders such as diabetes and osteoarthritis.