Neurocrine Biosciences, Inc. announced the presentation of new analyses from a Phase 4 randomized withdrawal study demonstrating significant patient-reported improvements in health-related quality of life and functional measures among adults aged 65 years and older with tardive dyskinesia who received continued treatment with INGREZZA®? (valbenazine) capsules. These post-hoc analyses of older adults expand on recently announced Phase 4 study results, which demonstrated that continued treatment with INGREZZ A improved functional status and quality of life measures across the general patient population.
Baseline socio-demographic and clinical characteristics of the participants were broadly similar to those of the KINECT®? 3 and KINECT®? 4 studies.
KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on TD using multiple clinically validated scales, including the Tardive dyskinesia Impact Scale (TDIS??). The TDIS is the only patient-reported outcome instrument designed for and validated in tardive dyskinesIA patients that measures the physical, social and emotional impact of the involuntary movements of the condition. The Tardive Dyskinesia Impact scale (TDIS) is a novel, psychometrically validated patient-reported outcome measure in TD.
INGREZZA is a selective vesicular monoamine transporter2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskineia and the treatment of chorea associated with Huntington's disease (HD).