First Drug for Tardive Dyskinesia Gains Approval
Neurocrine Biosciences announced that the Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules for the treatment of tardive dyskinesia in adults. Ingrezza is the first approved product indicated to treat adults with tardive dyskinesia.
The FDA approval was based on efficacy data of Ingrezza in a clinical study (n=234) of patients who received Ingrezza vs. placebo. After 6 weeks, patients who received Ingrezza showed improvement in the severity of abnormal involuntary movements vs. patients who received placebo. Sustained reductions in TD were seen through 48 weeks of treatment. There was no worsening seen in safety scale scores for depression, suicidal ideation, or behaviors.
Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. Ingrezza should not be used in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.
Ingrezza will be available as 40mg strength capsules in 30- and 90-count bottles. It will be available through a select pharmacy network starting next week.
For more information call (844) 647-3992 or visit Ingrezza.com.