Exposure-Response Analysis for Aripiprazole Once-Monthly in Patients Diagnosed With Bipolar I Disorder.

ABSTRACT: Aripiprazole once-monthly (AOM) is approved for the maintenance monotherapy treatment of bipolar I disorder (BP-I) in adults. A previously developed population pharmacokinetic model was validated by applying it to data from patients diagnosed with BP-I. The model was then used to generate aripiprazole exposures for an exposure-response model intended to describe the relationship between aripiprazole exposure and time to recurrence of any mood episode in patients with BP-I. The BP-I data were best described by a continuous model in which higher aripiprazole exposure was associated with a lower risk of recurrence. For each 1 ng/mL increase in aripiprazole plasma concentration, the predicted hazard for recurrence decreased by 0.34%. An aripiprazole plasma concentration of 95 ng/mL (clinically

SUBMITTER: Wang X 

PROVIDER: S-EPMC12583983 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature