The U.S. Food and Drug Administration (FDA) has approved valbenazine, trade name Ingrezza, for the treatment of tardive dyskinesia. Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements usually associated with lower facial and distal extremity musculature. Common signs include tongue protrusion, writhing of tongue, lip smacking, chewing, blinking, and grimacing. Dyskinesia can occur spontaneously but can also be drug-induced, notably by the dopamine 2 receptor blocking agents. The first medication approved to treat tardive dyskinesia, valbenazine is a selective inhibitor of vesicular monoamine transporter 2 (VMAT2), which packages monoamines, including dopamine, into synaptic vesicles of presynaptic neurons in the central nervous system.
Valbenazine was granted Fast Track, Priority Review, and Breakthrough Therapy designations by the FDA. In clinical trials, valbenazine significantly reduced symptoms of tardive dyskinesia relative to placebo through 6 weeks, with continued improvement seen through 48 weeks of treatment. The most common side effect was somnolence.
FDA Press Release
Neurocrine Press Release