The FDA ( Food and Drug Administration ) has approved Horizant Extended Release Tablets ( Gabapentin enacarbil ), a once-daily treatment for moderate-to-severe restless legs syndrome ( RLS ).

Restless legs syndrome 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 restless legs syndrome 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.

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 restless legs syndrome symptoms, compared with people taking 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.

Source: FDA, 2011

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Link: Xapedia - Medical Encyclopedia