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FDA approves new dosage of Ingrezza for tardive dyskinesia
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The FDA has approved an 80-mg capsule of Ingrezza for treatment of tardive dyskinesia in adults, according to a manufacturer-issued press release.
Ingrezza (valbenazine, Neurocrine Biosciences) is a selective vesicular monoamine transporter 2 inhibitor first approved by the FDA in April 2017.
Clinical study data indicated 80 mg of valbenazine significantly and rapidly improved tardive dyskinesia severity compared with placebo at 6 weeks (–3.2 vs. –0.1; P .001).
Researchers observed continued reductions through 48 weeks of treatment.
Valbenazine was generally well tolerated, with somnolence being the only adverse event that occurred at a rate of at least 5% and twice the rate of placebo.
Safety scale scores for depression and suicidal ideation or behaviors did not generally worsen.
Valbenazine has been studied in over 20 clinical trials among more than 1,000 individuals.
“Ingrezza continues to be the [tardive dyskinesia] treatment of choice,” Kevin C. Gorman, CEO of Neurocrine Biosciences, said in the release. “With the approval of the new 80-mg capsule, patients now have access to an even more convenient treatment option. Ingrezza is the only [tardive dyskinesia] therapy to offer simplified dosing with only one capsule once per day.”