FDA Approval of Gabapentin Enacarbil for RLS

Gabapentin enacarbil (marketed as Horizant) has been approved for the treatment of restless legs syndrome (RLS), the FDA announced on April 7, 2011.

Approval was based on two 12-week clinical trials in which patients who received the once-daily tablets had better overall improvement in their RLS symptoms than those who took a placebo.

Gabapentin enacarbil is a precursor of the antiepileptic gabapentin; therefore, it will carry the same warning as all epilepsy drugs about an increased risk for suicidality. Additionally, patients will receive a medication guide when filling their prescriptions. Common adverse effects include dizziness and drowsiness.