Phase 4 Data Support Effectiveness of Deutetrabenazine in Managing Tardive Dyskinesia, Chorea

Teva Pharmaceuticals announced data from the ongoing real-world phase 4 study, coined IMPACT-TD Registry, evaluating the efficacy of deutetrabenazine (Austedo) tablets and its extended-release tablet formulation (Austedo XR) in patients with tardive dyskinesia (TD). Overall, the findings showed that both treatments are associated with reduced severity of involuntary movements and improvements in patient-reported quality of life.¹

“The silent struggle of tardive dyskinesia, with its relentless, involuntary movements, can deprive patients of their quality of life and independence—real-world findings are so critical to inform how we innovate and improve the everyday lives of individuals living with this disease,” said Stacy Finkbeiner, Senior Medical Director, Movement Disorders and Psychiatry at Teva Pharmaceuticals, in a statement. ¹

Presented at the 2025 Neuroscience Education Institute Fall Congress, held November 6 to 9, in Colorado Springs, Colorado, the analysis evaluated a cohort of 27 adults with TD who were treated with deutetrabenazine or deutetrabenazine extended release. The study provided a questionnaire to patients after a 3-month treatment period that measured patient-reported impact across 5 key areas. Additionally, the study included patients with common comorbid psychiatric disorders, such as bipolar disorder (41%), anxiety disorder (37%), depression (26%), and schizophrenia (19%), reflecting a real-world patient population.

All told, findings showed meaningful improvement after 3 months across several areas, including speech/communication (77%), eating (75%), psychosocial impact (65%), activities of daily living (59%), and sleep/pain (50%). Most participants (85%) reported that their underlying mental health condition remained stable or improved based on the Patient Global Impression of Severity (PGIS) scale when treatment was used in addition to their mental health medications. At 3 months, the total motor score on the Abnormal Involuntary Movement Scale (AIMS) showed a mean decrease of -2.9, indicating a notable reduction in the severity of uncontrolled movements consistent with what was previously seen in trials.

Regarding the data, Finkbeiner added, “These data articulate patient experience and further validate clinical research showing how deutetrabenazine or deutetrabenazine extended release can help people living with tardive dyskinesia improve their symptoms while maintaining their mental health.”

deutetrabenazine and its extended-release are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the FDA for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. deutetrabenazine extended release is the once-daily, extended-release formulation of deutetrabenazine and both treatments are cleared for adults.

Read More: FDA Approves One Pill, Once-Daily Tablets of Deutetrabenazine for Tardive Dyskinesia, Chorea

Although deutetrabenazine and its extended-release treatments are approved to treat HD and TD, both have labels that indicate increased risk of depression, suicidal thoughts and behavior in patients with Huntington disease. Furthermore, both treatments are contraindicated in patients who are suicidal and in patients with untreated or inadequately treated depression.

Deutetrabenazine was originally approved as a twice daily treatment by the FDA in April 2017 and later had its label expanded months later to include the treatment of TD. Years later, in 2023, the FDA approved a once-daily, extended-release formulation of the agent, further allowing for more administration flexibility and improved adherence.² This came as a result of data from a phase 3 open-label, single-arm 2-cohort, multicenter ARC-HD extension study (NCT01897896) which showed that deutetrabenazine was safe and enhanced and maintained chorea in patients with HD over a 3-year period.³

One year later, a single, extra strength tablet was approved by the FDA, providing patients with tablets of varying strengths and a different form of administration than before. The one-pill, once-daily, extended-release tablet offers patients 4 tablet strengths, 30, 36, 42, or 48 mg, for both chorea associated with HD and TD.⁴

REFERENCES
1. AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Demonstrate Positive Real-world Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living. Teva Pharmaceuticals. News Release. November 7, 2025. Accessed November 25, 2025. https://www.globenewswire.com/news-release/2025/11/07/3184014/0/en/AUSTEDO-deutetrabenazine-tablets-and-AUSTEDO-XR-deutetrabenazine-extended-release-tablets-Demonstrate-Positive-Real-world-Impact-with-Patients-Reporting-Improvement-in-Involuntary-.html
2. Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets. News release. Teva. February 17, 2023. Accessed May 29, 2024. https://www.businesswire.com/news/home/20230217005357/en/Teva-Announces-FDA-Approval-of-AUSTEDO%C2%AE-XR-deutetrabenazine-Extended-Release-Tablets-a-New-Once-Daily-Formulation-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets
3. Teva announces results from 3-year study assessing the safety and tolerability of Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease. News release. October 18, 2022. Accessed May 29, 2024. https://www.businesswire.com/news/home/20221018005197/en/Teva-Announces-Results-from-3-Year-Study-Assessing-the-Safety-and-Tolerability-of-AUSTEDO%C2%AE-deutetrabenazine-Tablets-for-the-Treatment-of-Chorea-Associated-with-Huntington%E2%80%99s-Disease
4. Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day). News release. Teva Pharmaceuticals. May 29, 2024. Accessed May 29, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-austedo-xr-deutetrabenazine-extended-release-tablets-now-u.s.-fda-approved-as-a-one-pil/