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FDA Approves Horizant Extended Release Tablets for the Treatment of Restless Legs Syndrome
The FDA has approved a new drug, Horizant Extended-Release Tablets, for once a day use in treatment for moderate to severe cases of restless legs syndrome.
Restless legs syndrome (RLS) is an illness that causes a strong urge to move the legs. Individuals with restless legs syndrome describe unpleasant sensations in their legs, such as aching, burning, tingling, itching, or pulling. Moving their legs momentarily relieves these feelings.
The urge to move often arises when someone is inactive. The symptoms are usually severer in the evening and early morning.
Russell Katz, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, stated in an FDA news release that people with restless legs syndrome could experience significant distress from their symptoms.
He added that Horizant provides considerable help in treating these symptoms.”
The FDA approved Horizant after two 12-week studies were conducted in adults. Those studies showed a positive change in restless legs syndrome patients who were taking Horizant compared to those using a placebo.
Horizant’s active ingredient is Gabapentin Enacarbil, which becomes gabapentin in the system. Gabapentin is an antiseizure drug that is also used to treat RLS. Lifestyle changes – suchas exercising, adopting healthy sleep habits, and cutting back on tobacco, caffeine, and alcohol – arealso recommended.
According to the FDA, Horizant “may cause dizziness and drowsiness and can impair a person’s ability to operate complex machinery.” Like all antiseizure drugs, Horizant will go with a warning about the risk that it may trigger suicidal thoughts and actions in a few people. Horizant will also carry a medication guide describing its uses and risks.
Horizant is not recommended for patients who must sleep during the daytime and remain awake at night, according to a news release from the drug companies GlaxoSmithKline and XenoPort, which developed the drug.
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References and Resources
- About Restless Leg Syndrome
- The Placebo Effect
