Horizant Approved to Treat Restless Legs Syndrome

THURSDAY April 7, 2011 -- Horizant extended release tablets (gabapentin enacarbil) have been approved as a once-daily treatment for restless legs syndrome (RLS), a disorder that causes a strong desire to move the legs.

The disorder creates unpleasant sensations in the legs, including itching, tingling, burning or aching, which are temporarily relieved by moving the legs. A person with RLS usually has these sensations when inactive, typically in the early morning and evening, the FDA said in a news release.

Horizant was evaluated in a pair of 12-week trials among adults with moderate-to-severe RLS. People who took the drug reported improvement in RLS symptoms, compared to those who took an inactive placebo.

The drug's common side effects include drowsiness and dizziness, which could impair a person's ability to drive or use heavy machinery. The body absorbs Horizant as gabapentin, a drug used to treat epilepsy. Horizant's label will include a warning that drugs used to treat epilepsy may lead to suicidal thoughts and actions in some people, the FDA said.

Horizant was developed by drugmakers GlaxoSmithKline and Xenoport.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about restless legs syndrome.

Posted: April 2011


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