Written By: Pharmacally Medical News Desk
Tardive dyskinesia (TD) remains a persistent movement disorder affecting patients exposed to long-term antipsychotic medications and other dopamine antagonists. The disorder can lead to involuntary, repetitive movements, impacting quality of life physically, socially, and emotionally. Real-world studies are essential to evaluate benefits outside controlled trials, focusing on patient-reported outcomes (PROs) and daily functioning.
Valbenazine, marketed as INGREZZA by Neurocrine Biosciences, demonstrated significant benefits for physical and emotional well-being among patients with tardive dyskinesia according to new data from the post-marketing phase 4 KINECT-PRO studies, presented at the 2025 International Parkinson and Movement Disorders Society Congress (MDS).
About Valbenazine
Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor, FDA-approved since 2017 for the treatment of TD. It works by reducing abnormal dopamine signaling that underlies the involuntary movements seen in TD. Flexible dosing (40mg–80mg daily) allows for individualized treatment, and its tolerability profile is well established over years of clinical use.
About Tardive Dyskinesia
Tardive dyskinesia typically arises after prolonged use of antipsychotics and can be lifelong, characterized by involuntary facial, oral, or limb movements. It often leads to social isolation, emotional distress, and impaired functioning in daily life. Effective management focuses on symptom relief and restoration of life quality.
Post-Marketing Study Findings
The open-label, post-marketing KINECT-PRO study enrolled 59 adults with mild to severe TD and psychiatric diagnosis (schizophrenia spectrum, bipolar, depression). Out of these, 52 (88 %) completed Week 24, and 45 were evaluable for efficacy analysis. Over 24 weeks, 57.8% of participants achieved symptomatic remission as defined by an Abnormal Involuntary Movement Scale (AIMS) score ≤1. Patient-reported outcome measures showed
- A mean improvement of –8.0 units in the Tardive Dyskinesia Impact Scale, indicating reduced physical burden and better functioning overall.
- Social and family functioning improved (Sheehan Disability Scale reduction of –2.3 for social life, –1.6 for family life).
- EQ-5D-5L self-rated health increased by more than 13 points across all patient subgroups.
- Remission rates were higher at the 80mg dose (62.5%) versus 60mg (44.4%), but all doses provided meaningful gains.
Safety Profile
The most important and common adverse events associated with valbenazine are somnolence (sleepiness or sedation), dry mouth, and akathisia (restlessness). Other notable side effects include dizziness, constipation, headache, fatigue, and balance disorders such as gait disturbances and falls. Rare but serious risks include QT interval prolongation, hypersensitivity reactions like angioedema and rash, neuroleptic malignant syndrome, and symptoms resembling Parkinsonism, which may require dose adjustment or discontinuation. Overall, these effects are manageable, but patients should be monitored closely during treatment.
Key Opinions
Dr. Sanjay Keswani, Chief Medical Officer at Neurocrine, emphasized that “remission is achievable sooner than expected patients who reached remission experienced significant physical, social, and emotional improvements, making it an important treatment goal”. Investigators also highlighted the importance of evaluating real-world outcomes to align clinical goals with patient priorities.
The KINECT-PRO phase 4 study at MDS 2025 strongly demonstrates that valbenazine provides sustained improvements in physical symptoms and overall quality of life for patients with tardive dyskinesia. Its established safety and efficacy make remission a feasible goal in routine practice.
References
Neurocrine Biosciences Presents New Post-Hoc Analysis: Treatment with INGREZZA® (valbenazine) Capsules Achieves Earlier Remission of Tardive Dyskinesia Symptoms While Reducing Patient-Reported Disease Burden, 23 Sept 2025, Neurocrine Bioscience, https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-new-post-hoc-analysis-treatment
Dunayevich, A. Parameswaran, M. Bron, E. Franey, D. Sparta, C. Zeng, S. Mathias, J. Mcevoy. Valbenazine Improves the Burden and Symptoms of Tardive Dyskinesia: Topline Results from the Phase 4 KINECT-PRO Study [abstract]. Mov Disord.2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/valbenazine-improves-the-burden-and-symptoms-of-tardive-dyskinesia-topline-results-from-the-phase-4-kinect-pro-study/. Accessed October 11, 2025.