Horizant for Restless Legs Syndrome FDA Approved

Author: U.S. Food and Drug Administration
Published: 2011/04/10
Contents: Summary - Introduction - Main - Related

Synopsis: FDA approved drug Horizant provides significant help in treating restless legs syndrome symptoms.

Introduction

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).

Main Digest

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 www.ninds.nih.gov/disorders/restless_legs/restless_legs.htm

Approved Drugs: Questions and Answers www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

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.

Related Publications

Share This Information To:
𝕏.com Facebook Reddit

Page Information, Citing and Disclaimer

Disabled World is an independent disability community founded in 2004 to provide news and information to people with disabilities, seniors, their family and carers. You can connect with us on social media such as X.com and Facebook.

Cite This Page (APA): U.S. Food and Drug Administration. (2011, April 10). Horizant for Restless Legs Syndrome FDA Approved. Disabled World. Retrieved May 25, 2024 from www.disabled-world.com/health/neurology/sleepdisorders/restlesslegsyndrome/horizant.php

Permalink: <a href="https://www.disabled-world.com/health/neurology/sleepdisorders/restlesslegsyndrome/horizant.php">Horizant for Restless Legs Syndrome FDA Approved</a>: FDA approved drug Horizant provides significant help in treating restless legs syndrome symptoms.

Disabled World provides general information only. Materials presented are never meant to substitute for qualified medical care. Any 3rd party offering or advertising does not constitute an endorsement.