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Onset and Resolution of Key Adverse Events in Valbenazine-Treated Patients with Tardive Dyskinesia: Pooled Analyses from Two Long-Term Clinical Trials

Published online by Cambridge University Press:  10 May 2021

Stephen R. Marder
Affiliation:
University of California Los Angeles, David Geffen School of Medicine, Los Angeles, CA, USA
Jean-Pierre Lindenmayer
Affiliation:
New York University School of Medicine, New York, NY, USA
Chirag Shah
Affiliation:
Neurocrine Biosciences, Inc., San Diego, CA, USA
Tara Carmack
Affiliation:
Neurocrine Biosciences, Inc., San Diego, CA, USA
Angel S. Angelov
Affiliation:
Neurocrine Biosciences, Inc., San Diego, CA, USA
Leslie Lundt
Affiliation:
Neurocrine Biosciences, Inc., San Diego, CA, USA
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Abstract

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Objective

Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged exposure to antipsychotics and other dopamine receptor blocking agents. Long-term safety of the approved TD medication, valbenazine, was demonstrated in 2 clinical trials (KINECT 3 [NCT02274558], KINECT 4 [NCT02405091]). Data from these trials were analyzed post hoc to evaluate the onset and resolution of adverse events (AEs).

Methods

Participants in KINECT 3 and KINECT 4 received up to 48 weeks of once-daily valbenazine (40 or 80 mg). Data from these studies were pooled and analyzed to assess the incidence, time to first occurrence, and resolution for the following AEs of potential clinical interest: akathisia, balance disorder, dizziness, parkinsonism, somnolence/sedation, suicidal behavior/ideation, and tremor.

Results

In the pooled population (N=314), all AEs of potential clinical interest occurred in <10% of participants, with somnolence (9.6%), suicidal behavior/ideation (6.4%), and dizziness (5.7%) being the most common AEs. Mean time to first occurrence ranged from 36 days (akathisia [n=9]) to 224 days (parkinsonism [n=2]). By end of study (or last study visit), resolution of AEs was as follows: 100% (suicidal ideation/behavior, parkinsonism); >85% (somnolence/sedation, dizziness); >70% (akathisia, balance disorder, tremor).

Conclusions

In long-term clinical trials, the incidence of AEs of potential clinical interest was low (<10%) and most were resolved by end of treatment (>70–100%). All patients taking valbenazine should be routinely monitored for AEs, particularly those that may exacerbate the motor symptoms associated with TD.

Funding

Neurocrine Biosciences, Inc.

Type
Abstracts
Copyright
© The Author(s), 2021. Published by Cambridge University Press

Footnotes

Presenting Author: Stephen Marder