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.

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FDA Approves First Generic Ropinirole

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.

"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.

The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.

The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.