XenoPort, Inc. (Nasdaq: XNPT) announced today the inclusion of gabapentin enacarbil, the active ingredient in HORIZANT ® (gabapentin enacarbil) Extended-Release Tablets, as an initial therapy for chronic persistent restless legs syndrome/Willis-Ekbom disease (RLS/WED) in an updated treatment algorithm for patients with RLS/WED. The WED Foundation’s algorithm, published in the current issue of Mayo Clinic Proceedings, provides information for physicians determining treatment choices for RLS/WED based on disease severity, existing comorbidities and the long-term benefits and risks of each major class of medications.
The algorithm, first published in 2004, was updated to accommodate several changes in the RLS/WED treatment landscape, including additional knowledge of treatment with nonergot dopamine agonists, increased experience with calcium channel alpha-2-delta ligands and the fact that several long-acting drugs have become available. According to the revised algorithm, either non-ergot dopamine agonists or the calcium channel alpha-2-delta ligands are recommended as initial treatment for patients with chronic persistent RLS/WED, and the choice of the initial treatment should be based on the individual clinical features of RLS/WED in a given patient.
“This is the second publication of clinical guidance in two months that addresses treatment and disease management considerations for RLS/WED, indicating the urgency with which the neuroscience and broader physician communities are seeking to better treat this condition,” said Mark Buchfuhrer, M.D., Medical Director of the Southern California Restless Legs Syndrome Support Group, attending physician at Downey Regional Medical Center in Downey, Calif., and member of the WED Foundation’s Medical Advisory Board and the International RLS Study Group. “This algorithm reflects evidence-based assessments and expert opinion from practical experience, and hopefully will serve as a much needed tool for physicians treating the estimated five million moderate-to-severe RLS/WED patients nationwide.”
“Gabapentin enacarbil is the only non-dopamine agonist and member of the calcium channel alpha-2-delta-ligand class that is approved by the FDA for the treatment of moderate-to-severe primary RLS. We are excited that the updated algorithm recognizes gabapentin enacarbil as an appropriate initial treatment option for patients with chronic persistent RLS/WED,” stated Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, Inc. “XenoPort recognizes that many RLS/WED patients have their disease for life and is committed to understanding the long-term needs of these patients.”