FDA Approval: INGREZZA
FDA BRIEF: Week of April 10, 2017
INGREZZA (valbenazine) capsules
Neurocrine Biosciences, San Diego, CA
INDICATION: Treatment of adults with tardive dyskinesia
ADDRESSING UNMET NEED:
- Neurological disorder characterized by repetitive involuntary movements
- Can be disabling and can further stigmatize patients with mental illness
- Serious side effect seen in patients antipsychotic medications
- First drug for the treatment
REG PATHWAY: NDA
- Fast Track, Priority Review and Breakthrough Therapy designations.
- Postmarketing Requirements: In vitro studies, PK studies, clinical dependence and withdrawal symptom assessment study
MECHANISM OF ACTION: Reversible inhibition of vesicular monoamine transporter 2 (VMAT2) that regulates monoamine uptake from cytoplasm to synaptic vesicle for storage and release
EFFICACY:
- Randomized, double-blind, placebo-controlled trial, n=234, patients with moderate to severe tardive dyskinesia, INGREZZA vs. placebo, 6 weeks, then on INGREZZA for 48 weeks
- Primary efficacy measure: Abnormal Involuntary Movement Scale (AIMS) change from baseline
- AIMS change statistically significantly different from placebo; consistent across multiple subgroups
SAFETY:
- Serious side effects: Sleepiness, QT prolongation.
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