Evoke Pharma announces presentation of real-world analyses of TD

Evoke Pharma announced the presentation of a real-world data analyses demonstrating a lower risk of tardive dyskinesia, TD, associated with metoclopramide usage compared to previous reports at the world's premier gastroenterology conference, Digestive Disease Week, DDW, 2022, which is taking place from May 21-24 in San Diego, CA. The poster entitled Revisiting the Risk of Tardive Dyskinesia with Metoclopramide Use: A Real-World Data Driven Epidemiology Study from 2011-2020 was awarded a "Poster of Distinction" by the American Gastroenterological Association, AGA, for poster presentations at DDW. Evoker's flagship product, GIMOTI, is an FDA-approved novel nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. This analysis is the largest examination ever conducted to understand the risk of TD. The retrospective analysis was conducted with administrative claims data representing approximately 35% of the US population using the Truven Health MarketScan Commercial Database. The data gathered between January 1, 2011 and December 31, 2020, comprised an excess of 300 unique employers, 25 different health plans, and 240M covered lives studying patients with at least twelve months of enrollment in a health insurance plan. Results of the study concluded that TD is rare among metoclopramide-treated patients, with an incidence of 33.4 per 100,000, and among metoclopramide-treated gastroparesis patients, it was 98.8 per 100,000. In addition, age and sex appear to be significant risk factors for TD, with the highest TD incidence reported among elderly females. Additional risk factors for TD include renal dysfunction, coadministration of DRBAs, diagnosis of mental health disorders, and diabetes. The incidence of TD was also found to increase with prolonged metoclopramide use, with the greatest risk of TD observed after 24 to 48 months of chronic metoclopramide use