Poster
186
(#186) Once-Daily Valbenazine for the Treatment of Tardive Dyskinesia in Elderly Adults and Other Special Populations
Psych Congress 2025
Abstract: Introduction: Valbenazine is a uniquely selective VMAT2 inhibitor approved for tardive dyskinesia (TD) and Huntington's disease chorea. Along with a higher risk for TD, elderly patients may have more severe TD impacts, more comorbid conditions and polypharmacy, and declining CYP2D6 metabolism. These factors make treating TD in elderly patients more challenging.
Methods: Data reported are from: 1) post-hoc analyses of data from elderly adults (≥65 years) in two clinical trials (NCT02274558, NCT02405091) in which participants received up to 48 weeks of once-daily valbenazine 40 or 80 mg; 2) Phase 1 pharmacokinetic studies of valbenazine in special patient populations; and 3) valbenazine prescribing information, including the approved sprinkle formulation (for patients with dysphagia and/or pill aversion).
Results: Elderly participants receiving long-term valbenazine treatment experienced robust improvements on the Abnormal Involuntary Movement Scale, Clinical Global Impression of Change-Tardive Dyskinesia, and Patient Global Impression of Change. Valbenazine was generally well tolerated, and the data support the FDA-approved recommendation of no required dose reduction in elderly patients. Pharmacokinetic study results suggest that no dose adjustment is necessary in patients with mild-to-severe renal impairment or mild hepatic impairment; dosage reduction is recommended for moderate/severe hepatic impairment, poor CYP2D6 metabolizers, and concomitant use of strong CYP2D6 or CYP3A4 inhibitors.
Conclusions: Long-term clinical trials have demonstrated valbenazine to be effective and generally well-tolerated in elderly patients. Effects of hepatic impairment, renal impairment, poor CYP2D6 metabolism, and concomitant medications on valbenazine exposure have also been studied in clinical trials, allowing for data-driven dosing recommendations in these special populations.
Short Description: Valbenazine is approved for tardive dyskinesia (TD) and Huntington's disease chorea. Data from various sources were summarized to provide key information about valbenazine use in elderly patients with TD, a population that may be challenging to treat, and in other special populations. In brief, valbenazine was generally safe and effective in elderly patients with TD, with no dose reduction required in this population or other special populations (e.g., renal impairment, mild hepatic impairment).
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
Methods: Data reported are from: 1) post-hoc analyses of data from elderly adults (≥65 years) in two clinical trials (NCT02274558, NCT02405091) in which participants received up to 48 weeks of once-daily valbenazine 40 or 80 mg; 2) Phase 1 pharmacokinetic studies of valbenazine in special patient populations; and 3) valbenazine prescribing information, including the approved sprinkle formulation (for patients with dysphagia and/or pill aversion).
Results: Elderly participants receiving long-term valbenazine treatment experienced robust improvements on the Abnormal Involuntary Movement Scale, Clinical Global Impression of Change-Tardive Dyskinesia, and Patient Global Impression of Change. Valbenazine was generally well tolerated, and the data support the FDA-approved recommendation of no required dose reduction in elderly patients. Pharmacokinetic study results suggest that no dose adjustment is necessary in patients with mild-to-severe renal impairment or mild hepatic impairment; dosage reduction is recommended for moderate/severe hepatic impairment, poor CYP2D6 metabolizers, and concomitant use of strong CYP2D6 or CYP3A4 inhibitors.
Conclusions: Long-term clinical trials have demonstrated valbenazine to be effective and generally well-tolerated in elderly patients. Effects of hepatic impairment, renal impairment, poor CYP2D6 metabolism, and concomitant medications on valbenazine exposure have also been studied in clinical trials, allowing for data-driven dosing recommendations in these special populations.
Short Description: Valbenazine is approved for tardive dyskinesia (TD) and Huntington's disease chorea. Data from various sources were summarized to provide key information about valbenazine use in elderly patients with TD, a population that may be challenging to treat, and in other special populations. In brief, valbenazine was generally safe and effective in elderly patients with TD, with no dose reduction required in this population or other special populations (e.g., renal impairment, mild hepatic impairment).
Name of Sponsoring Organization(s): Neurocrine Biosciences, Inc.
