XenoPort, Inc. (Nasdaq: XNPT) announced today the inclusion of gabapentin enacarbil, the active ingredient in Horizant ® (gabapentin enacarbil) Extended-Release Tablets, as a first-line therapy in new treatment guidelines created by the Task Force of the International Restless Legs Syndrome Study Group (IRLSSG). The manuscript, published in the current issue of Sleep Medicine, provides information for physicians determining treatment choices for restless legs syndrome/Willis-Ekbom Disease (RLS/WED) based on the long-term benefits and risks of each major class of medications. Horizant is the only non-dopamine agonist and the only alpha-2-delta ligand approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe primary restless legs syndrome in adults.
“The last few years have seen tremendous advances in our knowledge of both the etiology of RLS/WED and its effective treatment,” stated Diego Garcia-Borreguero, M.D., Chair, International Restless Legs Study Group and Director, Sleep Research Institute, Madrid, Spain. “These guidelines are an important tool for guiding physicians in the choice for pharmacotherapy of patients requiring long-term treatment of RLS/WED symptoms.”
The guidelines state that either dopamine-receptor agonists or the alpha-2-delta ligands, which include gabapentin enacarbil, are the first-line treatment for patients with RLS/WED, and that the choice of the initial treatment should be based on the individual clinical features of RLS/WED in a given patient. The guidelines indicate that alpha-2-delta ligands should be considered for initial treatment in patients with severe sleep disturbance (disproportionate to other RLS/WED symptoms), comorbid insomnia or anxiety, RLS/WED-related or comorbid pain, or a history of an impulse control disorder (ICD) or anxiety. In addition, the guidelines recommend that patients with clinically significant daytime symptoms should be treated with a long-acting agent. The published guidelines are available at www.IRLSSG.org.
“We are happy to see that Horizant, the only non-dopamine agonist and the only alpha-2-delta ligand approved by the FDA, is being recognized as an important treatment option for patients with RLS/WED,” stated Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, Inc. “There is growing recognition that the dopamine agonists are not appropriate or sufficient for long-term treatment of all RLS/WED patients. We are proud to contribute an alternative first-line treatment to the RLS/WED community.”About Restless Legs Syndrome RLS/WED is a neurological condition that causes an irresistible urge to move the legs. This urge is usually caused or accompanied by unpleasant sensations of burning, creeping, tugging or tingling inside the patients’ legs, ranging in severity from uncomfortable to painful. These RLS-related symptoms typically begin or worsen during periods of rest or inactivity, particularly when lying down or sitting, and may be temporarily relieved by movement such as walking or massaging the legs. Symptoms often worsen at night, and disturbed sleep is a common result of RLS. Left untreated, moderate-to-severe primary restless legs syndrome may cause exhaustion, daytime fatigue, inability to concentrate and impaired memory.