Austedo Phase 4 Data Shows Reduction in Tardive Dyskinesia Severity

Phase 4 data from Teva Pharmaceuticals on deutetrabenazine (Austedo) showed significant reduction in involuntary movement and improvements in quality of life in adults with tardive dyskinesia.¹ Up to 77% of participants taking Austedo reported that after 3 months there were meaningful improvements in impacts of tardive dyskinesia, according to data presented at the 2025 Neuroscience Education Institute Fall Congress from November 6 to 9.

In this interim analysis of the phase 4 study IMPACT-TD, 27 adults with tardive dyskinesia who were treated with Austedo or Austedo extended release (XR) were evaluated after 3 months. Patients reported the impact of the drug on 5 key areas of quality of life, using the IMPACT-TD Pro 30-question scale. Patients included in the study had comorbid psychiatric disorders of bipolar disorder (41%), anxiety disorder (37%), depression (26%), and schizophrenia (19%).

"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,” commented Stacy Finkbeiner, senior medical director of movement disorders and psychiatry at Teva, in a press release. “These data articulate patient experience and further validate clinical research showing how Austedo or Austedo XR can help people living with tardive dyskinesia improve their symptoms while maintaining their mental health, something we care deeply about in our mission at Teva to improve the lives of patients,” she added.

After 3 months on Austedo or Austedo XR, patients reported meaningful improvements in speech/communication (77% reported improvement), eating (75%), psychosocial impact (65%), activities of daily living (59%), and sleep/pain (50%). Data showed a mean decrease of 2.9 for the total motor score on the Abnormal Involuntary Movement Scale. This decrease indicates a notable reduction in severity of uncontrolled movements for patients. Most patients (85%) taking Austedo in addition to their usual psychiatric medication reported that their psychiatric condition remained stable or improved, as measured by the Patient Global Impression of Severity scale. These findings, from part B of the IMPACT-TD registry, show Austedo can improve functioning in everyday tasks and activities of daily living due to reduction of involuntary movement. An earlier part A of this study showed the broad impact of tardive dyskinesia beyond physical movements as well.

Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor. Involuntary movements are associated with unstable dopamine signaling through these VMAT2; maintaining consistent dopamine levels is important for regulation of movement disorders like tardive dyskinesia.² The chemical structure of deutetrabenazine causes fewer plasma fluctuations, which may contribute to the lower prevalence of adverse effects caused by this drug.

Austedo standard and XR tablets are currently indicated for adults for the treatment of chorea in Huntington disease and tardive dyskinesia. Austedo is the first VMAT2 inhibitor approved by the US Food and Drug Administration for adults with tardive dyskinesia.³ It is not currently approved for pediatric patients.

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. Press release. November 7, 2025. Accessed November 11, 2025. https://www.tevapharm.com/news-and-media/latest-news/austedo-deutetrabenazine-tablets-and-austedo-xr-deutetrabenazine-extended-release-tablets-demonstra/

2. Solmi M, Pigato G, Kane JM, et al. Treatment of tardive dyskinesia with VMAT-2 inhibitors: a systematic review and meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2018;12:1215-1238.

3. Mechanism of action. Austedo. Accessed November 11, 2025. https://www.austedohcp.com/tardive-dyskinesia