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).
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
“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.