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]

Core Viewpoint - Evoke Pharma, Inc. announced the acceptance of a new abstract for presentation at Digestive Disease Week 2025, focusing on the incidence of tardive dyskinesia in patients treated with metoclopramide [1][3] Company Overview - Evoke Pharma is a specialty pharmaceutical company that develops treatments for gastrointestinal disorders, particularly known for GIMOTI, a nasal spray formulation of metoclopramide for diabetic gastroparesis [6][7] - GIMOTI is the only FDA-approved treatment for diabetic gastroparesis, addressing a significant need in the market [3][7] Research and Findings - The upcoming presentation will compare the incidence rates of tardive dyskinesia in patients receiving continuous versus intermittent oral metoclopramide treatment, utilizing real-world data from over 100 million U.S. patients [2][4] - The research aims to clarify the long-term safety profile of metoclopramide, particularly regarding tardive dyskinesia, to support informed prescribing decisions [3][4] Event Details - The abstract titled "Comparison of the Incidence of Tardive Dyskinesia in Patients Receiving Continuous vs Intermittent Oral Metoclopramide" will be presented by Pierantonio Russo, MD, during a session on gastroparesis and small intestinal dysmotility on May 5, 2025 [4] - The abstract will be accessible to attendees via the DDW ePosters site and mobile app starting May 4, 2025 [4] Industry Context - Digestive Disease Week (DDW) is a major international event for professionals in gastroenterology, showcasing advancements in GI research and medicine [8]