Population Pharmacokinetic and Exposure-Efficacy Analyses of Valbenazine in Patients with Huntington's Disease: Supporting Dose Selection for Chorea Management.

ABSTRACT: Valbenazine improved chorea in individuals with Huntington's disease compared to placebo in a phase 3, placebo-controlled study (KINECT-HD). Population pharmacokinetics (PK) and exposure-response (E-R) analyses focused on understanding the PK characteristics of valbenazine and its active metabolite, [+]-α-dihydrotetrabenazine ([+]-α-HTBZ), and their correlation with clinical efficacy measured by the total maximal chorea (TMC) score. Consistent with previous analyses, a two-compartmental population PK model adequately described valbenazine and [+]-α-HTBZ plasma disposition, generating reliable individual-predicted exposure levels for sequential E-R analysis. The distributions of individual-predicted steady-state exposures of valbenazine and [+]-α-HTBZ were found to largely overlap between p

SUBMITTER: Nguyen HQ 

PROVIDER: S-EPMC12649288 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature