The dose of gabapentin enacarbil should be adjusted in subjects with renal impairment (creatinine clearance 30 to 59 mL/min); gabapentin enacarbil 600 mg should be administered on Day 1, Day 3, and every day thereafter. Gabapentin enacarbil is not recommended in patients with creatinine clearance less than 30 mL/min or in patients on hemodialysis.
In three 12-week clinical trials, the two most commonly observed adverse reactions for gabapentin enacarbil 600 mg per day (n=163), gabapentin enacarbil 1200 mg per day (n=269), and placebo (n=245), respectively, were somnolence/sedation (20%, 27%, and 6%) and dizziness (13%, 22%, and 4%).
Please see full Prescribing Information and Medication Guide available at www.gsk.com.
About Restless Legs Syndrome (also known as Ekbom Disease)Restless Legs Syndrome is a neurological disorder characterized by an urge to move the legs usually caused or accompanied by uncomfortable and unpleasant sensations in the legs. Estimates of the prevalence for Restless Legs Syndrome in adult patients with medically-significant symptoms ranged between 1.5% to 2.7% in U.S. and/or western European populations. 1,2,3,4 Key diagnostic criteria for Restless Legs Syndrome are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations, symptoms begin or worsen during periods of rest or inactivity such as lying or sitting, symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues, and symptoms are worse or occur only in the evening or night. Studies have identified potential gene variants associated with Restless Legs Syndrome. Research in this area is ongoing. Conference Call and Webcast Information XenoPort will host a conference call at 9:00 a.m. Eastern Time tomorrow to discuss the approval of Horizant for moderate-to-severe primary Restless Legs Syndrome. To access the conference call via the Internet, go to www.XenoPort.com. To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 1-706-679-1417. The replay of the conference call may be accessed after 12:00 p.m. Eastern Time tomorrow via the Internet at www.XenoPort.com, or via phone at 1-800-642-1687 for domestic callers or 1-706-645-9291 for international callers. The reference number to enter both the call and replay of the call is 58624319. GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com . XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. Horizant is XenoPort’s first approved product. GlaxoSmithKline holds commercialization rights and certain development rights for gabapentin enacarbil in the United States. Gabapentin enacarbil is also being developed in partnership with Astellas Pharma Inc. for the potential treatment of Restless Legs Syndrome in Japan. If approved in Japan, gabapentin enacarbil would be marketed under a different trade name. XenoPort holds all other world-wide rights and has co-promotion and certain development rights to gabapentin enacarbil in the United States. XenoPort’s pipeline of product candidates includes potential treatments for patients with neuropathic pain, spasticity and Parkinson’s disease. XenoPort’s product candidates were discovered and developed by XenoPort utilizing its patented Transported Prodrug™ technology. Except for gabapentin enacarbil, XenoPort owns rights to all of its product candidates. To learn more about XenoPort, please visit the Web site at www.XenoPort.com . Editor’s Note: This product was formerly referred to as XP13512, GSK1838262 and the proposed trade name Solzira™.