Benzinga | Aug 20, 2021 08:02AM EDT

Teva Reports Post Hoc Analysis Of Long-Term Data Examining Treatment With AUSTEDO Tablets In Adult Patients With Tardive Dyskinesia

Findings Published in The American Journal of Geriatric Psychiatry

TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a post hoc analysis of a long-term, 3-year open-label extension (OLE) study examining efficacy and safety endpoints for the use of AUSTEDO (deutetrabenazine) tablets in younger (<55 years) and older (?55 years) patients with tardive dyskinesia (TD). The findings, published online in The American Journal of Geriatric Psychiatry, evaluated the long-term use of AUSTEDO with the total motor Abnormal Involuntary Movements Scale (AIMS) score, and measures of treatment success and quality of life.

TD affects about 500,000 people in the United States and approximately 25 percent of the global population taking first-and second-generation antipsychotics.1,2 It is usually a result of prolonged use of treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses like schizophrenia, bipolar disorder and depression, as well as certain anti-nausea medications. Notably, TD incidence rates are estimated to be three to five times higher in patients over 50 years old.3

"This analysis helps further our understanding of AUSTEDO as a treatment that may help alleviate uncontrolled movements in adults but is particularly compelling when considering treatment of older patients," said Martha Sajatovic, MD, University Hospitals Cleveland Medical Center at Case Western Reserve University School of Medicine in Ohio. "Symptoms of TD can worsen in severity over time, especially in patients 55 years and older who have had long-term treatment with an antipsychotic prescription. As this occurs, they may experience balance and coordination issues, putting them at an increased risk for falls that may be especially concerning."

This post hoc analysis was conducted to potentially inform treatment decisions in younger and older patients with TD treated with deutetrabenazine. Data were derived from the single-arm 3-year OLE study in patients that had successfully completed either the Phase 3 ARM-TD or AIM-TD study (n=337). The safety profile of AUSTEDO was generally similar across both the younger and older patients. Due to the uncontrolled nature of the data and post hoc analysis, no determination of statistical significance can be made.