In this JCP video abstract, Jonathan M. Meyer, MD (University of California, San Diego) and Leslie Citrome, MD (New York Medical College) walk through a study of once-monthly paliperidone palmitate for adults with schizophrenia or schizoaffective disorder. The 351 mg dose (LY03010) became available in the US in April 2025, approved as a single initiation injection followed by monthly maintenance doses up to 234 mg. Using a population pharmacokinetic model built from two phase 1 studies, the investigators simulated steady-state paliperidone exposure when 351 mg is given at longer intervals, asking whether the higher dose could support more flexible maintenance schedules.
The simulations lined up several practical equivalencies. At steady state, 351 mg every four weeks produced exposure comparable to 234 mg every three weeks; 351 mg every six weeks approximated 234 mg every four weeks; and 351 mg every eight weeks produced maximum concentrations between those of 234 mg and 156 mg every four weeks, with troughs comparable to 117 mg every four weeks. The presenters frame the clinical implication carefully: these are simulation data, but they suggest 351 mg could offer alternative maintenance strategies that support effectiveness or adherence. For patients with an inadequate response to the maximum approved once-monthly dose, 351 mg every four weeks may be a viable consideration, while every-six- or every-eight-week dosing could add flexibility to maintenance planning.
