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FDA approves Horizant to treat restless legs syndrome

Thu, 04/07/2011 - 4:20am

For Immediate Release: April 7, 2011

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA approves Horizant to treat restless legs syndrome

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).

RLS is a disorder that causes a strong urge to move the legs. This urge often occurs with unpleasant feelings in the legs. People who have RLS describe feeling pulling, itching, tingling, burning, or aching in their legs, and moving the legs temporarily relieves these feelings. The urge to move often happens when a person is inactive, and the symptoms typically are worse in the evening and early morning.

“People with restless legs syndrome can experience considerable distress from their symptoms,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Horizant provides significant help in treating these symptoms.” 

The effectiveness of Horizant was studied in two 12-week clinical trials in adults. The trials showed that people taking the medication had an improvement in their RLS symptoms, compared with people taking an inactive pill (placebo).

Horizant will be dispensed with an FDA-approved Medication Guide that explains the drug’s uses and risks. Horizant may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery.

Horizant contains gabapentin enacarbil that becomes gabapentin, a drug used to treat seizures in people with epilepsy, when absorbed into the body. All drugs used to treat epilepsy carry warnings that they may cause suicidal thoughts and actions in a small number of people. Horizant will have the same warning.

Horizant was developed by GlaxoSmithKline of Research Triangle Park, N.C., and Xenoport of Santa Clara, Calif.

For information:

National Institute of Neurological Disorders and Stroke: Restless Legs Syndrome Information Page

 

Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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