FDA Approves New Dosage Strength for Ingrezza
The Food and Drug Administration has approved a new dosage strength for Ingrezza (valbenazine; Neurocrine Biosciences). This vesicular monoamine transporter 2 (VMAT2) inhibitor, indicated for the treatment of adults with tardive dyskinesia, will now be available as an 80mg capsule, in addition to the already approved 40mg capsule.
The approval of the new strength was based on studies which showed Ingrezza 80mg provided significant improvement in tardive dyskinesia severity compared to placebo at 6 weeks (–3.2 vs. –0.1; P≤0.001), with continued reductions seen through 48 weeks.
"With the approval of the new 80mg capsule, patients now have access to an even more convenient treatment option," said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences. "Ingrezza is the only [tardive dyskinesia] therapy to offer simplified dosing with only one capsule once per day."
The 80mg capsule is expected to be available in 30-count bottles within the next two weeks.
For more information visit Neurocrine.com.