Navigation Links
FDA Approves Horizant To Treat Restless Legs Syndrome
Date:4/7/2011

SILVER SPRING, Md., April 7, 2011 /PRNewswire-USNewswire/ -- 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).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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

Approved Drugs: Questions and Answers
http://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.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves New Treatment for Rare Form of Thyroid Cancer
2. FDA Approves Special Protocol Assessment for Phase 3 Trial of Polaris Groups Cancer Therapeutic, ADI-PEG 20, in the Treatment of Hepatocellular Carcinoma
3. FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec
4. FDA Approves New Treatment for a Type of Late-Stage Skin Cancer
5. FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
6. FDA Approves Gadavist for Central Nervous System Scans
7. U.S. FDA Approves Bayers Gadavist™ (Gadobutrol) Injection for MRI of the Central Nervous System
8. FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery
9. FDA Approves BENLYSTA® for Lupus in Breakthrough for Millions of Sufferers
10. FDA Approves Revised Alphanate® Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD
11. UPDATE: FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)... 27, 2017  Commended for their devotion to personalized service, ... as number one in the South Florida Business Journal,s 50 ... 5000 yearly list, the national specialty pharmacy has found its ... will soon be honored by SFBJ as the 2017 ... Set to receive his award in October, Bardisa said ...
(Date:9/23/2017)... -- Janssen Biotech, Inc. (Janssen) announced today that it ... Food and Drug Administration (FDA) for the Biologics License ... of moderately to severely active rheumatoid arthritis (RA). The ... to further evaluate the safety of sirukumab in the ... "We are disappointed by ...
(Date:9/19/2017)... Sept. 19, 2017   ZirMed Inc ., a recognized ... announced that it has been ranked #1 by its users ... Rankings 2017 User Survey. ZirMed was recognized as the ... hospitals and medical centers over 200 beds and holds one ... technology user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
Breaking Medicine News(10 mins):