Do you suffer from unpleasant feelings in your legs when you’re sitting down? Do you feel like you have to move your legs to get rid of that throbbing, tingling, itching and burning in your legs? If you do, you may be suffering from restless legs syndrome (RLS), a condition that affects the nerves of around 10 out of every 100 persons throughout the world.
Moving your legs can provide temporarily relief, but what if you have to sit through a five-hour exam? Or are you an executive who has to sit still in long corporate meetings?
“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. RLS is a spectrum neurological disorder and unpleasant sensations can range from mildly uncomfortable to irritating to painful.
For people with RLS, the urge to move often happens when they are inactive, and the symptoms typically worsen in the evening and early morning. Many RLS sufferers have difficulty falling asleep and staying asleep, and thus suffer from daytime fatigue, difficulty in concentrating and impaired memory that makes daily tasks hard to accomplish. RLS can also make traveling difficult and can cause depression.
The good news is that relief for RLS symptoms has been available since April. On that month, the U.S. Food and Drug Administration approved the Horizant Extended Release Tablets (gabapentin enacarbil), a drug developed by GlaxoSmithKline and Xenoport as a once-daily treatment for moderate-to-severe RLS. “Horizant provides significant help in treating these symptoms,” Dr. Katz said.
Horizant contains gabapentin enacarbil. When absorbed by the body, it becomes gabapentin, a drug used to treat seizures in people with epilepsy. Two 12-week clinical trials in adults have shown Horizant to be effective: The trials showed that patients taking Horizant had diminished RLS symptoms, compared with those who were given a placebo.
As all drugs used to treat epilepsy may cause suicidal thoughts and actions in some people, Horizant will carry that warning. In addition, Horizant may also cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery. Thus, the drug will be dispensed with an FDA-approved Medication Guide that explains the drug’s uses and risks.
The FDA is an agency within the U.S. Department of Health and Human Services that aims to protect 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.
The medical information in this post comes from a U.S. FDA news release:
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