New Formulation of Tardive Dyskinesia Drug Approved by FDA
Ingrezza is a selective VMAT2 inhibitor that was the first FDA-approved product indicated to treat adults with tardive dyskinesia.
FDA officials have approved an 80-mg capsule strength of Neurocrine Biosciences’ valbenazine (Ingrezza) for the treatment of adults with tardive dyskinesia (TD), the company announced in a press release.
Ingrezza, a selective VMAT2 inhibitor, initially received the agency’s nod on April 11, 2017, making it the first FDA-approved product indicated to treat adults with TD. The drug is taken as 1 capsule, once per day.
The drug is thought to work by reducing the amount of dopamine released in the part of the brain that controls movement and motor function, which helps to regulate nerve signaling in adults with TD.
The new approval is based on clinical studies that demonstrated that 80 mg provided significant, rapid, and meaningful improvement in TD severity. The 80-mg strength was compared to a placebo at 6 weeks, with separation in reduced severity seen as early as 2 weeks and continued reductions observed through 48 weeks of treatment. No worsening in safety scale scores for depression, suicidal ideation, or suicidal behaviors was observed. The most common adverse event reported by trial participants was somnolence.
The new 80-mg capsule is expected to be available for patients within 2 weeks through a select pharmacy network.
Neurocrine Announces FDA Approval of 80 mg INGREZZA® (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD) [news release]. San Diego. Neurocrine’s website. http://phoenix.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=2304824. Accessed October 6, 2017.