The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) extended-release tablets for the treatment of restless leg syndrome.
Developed by GlaxoSmithKline and US-based Xenoport, Horizant is a once-daily treatment for moderate-to-severe restless leg syndrome, a disorder that causes a strong urge to move the legs and great discomfort.
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The effectiveness of Horizant was studied in two 12-week clinical trials in adults, which showed that people taking the medication had an improvement in their restless leg syndrome symptoms, compared with people taking placebo.
Symptoms include pulling, itching, tingling, burning, or aching in the legs, and moving the legs temporarily relieves these feelings.
Russell Katz, managing director for the FDA’s Division of Neurology Products, said, “People with restless leg syndrome can experience considerable distress from their symptoms. Horizant provides significant help in treating these symptoms.”
Horizant contains gabapentin enacarbil, which becomes gabapentin, a drug that also treats seizures in people with epilepsy, when absorbed by the body.
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