INGREZZA® SPRINKLE (valbenazine) capsules

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Neurocrine Biosciences Presents Data Adding to the Growing Body of Evidence Demonstrating Functional and Quality of Life Improvements in Patients with Tardive Dyskinesia
Prnewswire· 2025-05-16 12:25
Core Insights - Neurocrine Biosciences presented new analyses from a Phase 4 randomized withdrawal study showing that patients with tardive dyskinesia who continued treatment with INGREZZA® (valbenazine) capsules reported improvements in functional and health-related quality of life measures [1][2] - The findings were presented at the 2025 ISPOR Conference, highlighting the clinically meaningful improvements in patients' quality of life due to INGREZZA treatment [1][2] Study Details - The analyses were based on data from 127 patients in a Phase 4, double-blind, placebo-controlled study, where patients received up to 80 mg of INGREZZA for eight weeks before being randomized to continue treatment or receive a placebo for an additional eight weeks [2][3] - Significant improvements were observed in health-related quality of life (HRQoL) measures, including mobility, self-care, usual activities, and pain/discomfort, with placebo-adjusted differences noted in anxiety/depression and mobility [3][4] Health-Related Quality of Life Improvements - Patients receiving INGREZZA for eight weeks showed improvements in HRQoL dimensions, with changes from baseline reported as follows: mobility (-0.27), self-care (-0.28), usual activities (-0.36), and pain/discomfort (-0.34) [3] - Continued treatment for an additional eight weeks resulted in further improvements, including a placebo-adjusted difference in mobility of -0.34 and anxiety/depression of -0.38 compared to the placebo group [3] Functional Impairment Improvements - In the open-label portion of the study, patients reported significant improvements in work/school (-1.37), social life (-1.65), family/home life (-1.30), and total Sheehan Disability Scale (SDS) score (-4.28) after eight weeks of treatment [4] - Continued treatment for an additional eight weeks led to further improvements in social life (-0.95) and family/home life (-0.89) compared to those receiving placebo [4] About INGREZZA - INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating adults with tardive dyskinesia and chorea associated with Huntington's disease [12][13] - The drug is designed to inhibit dopamine release, potentially reducing uncontrollable movements associated with these conditions [13][14]