Company: Neurocrine Biosciences
Approval Status: Approved April 2017
Specific Treatments: tardive dyskinesia
Therapeutic Areas Neurology
Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Ingrezza is specifically indicated for the treatment of adults with tardive dyskinesia.
Ingrezza is supplied as a capsule for oral administration. The initial dose is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients. Administer Ingrezza orally with or without food. Please see drug label for specific dose modifications.
The FDA approval of Ingrezza was based on a randomized, double-blind, placebo-controlled trial of Ingrezza conducted in 234 patients with moderate to severe tardive dyskinesia and underlying schizophrenia, schizoaffective disorder, or a mood disorder. The primary efficacy endpoint was the mean change from baseline in the AIMS dyskinesia total score at the end of Week 6. The change from baseline for two fixed doses of Ingrezza (40 mg or 80 mg) was compared to placebo. The change from baseline in the AIMS total dyskinesia score in the 80 mg Ingrezza group was statistically significantly different from the change in the placebo group.
Adverse effects associated with the use of Ingrezza may include, but are not limited to, the following:
Mechanism of Action
Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor. The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.
For additional information regarding Ingrezza or tardive dyskinesia, please visit http://ingrezza.com/