Population pharmacokinetic modeling and stochastic simulations to support pediatric dose selection of pimavanserin

Conference: American College of Neuropsychopharmacology

Pimavanserin is a selective serotonin receptor-modulating agent with inverse agonist/antagonist activity at the 5HT2A receptor, and to a lesser extent at the 5HT2C receptor. The safety and efficacy of pimavanserin 34 mg has been characterized in both placebo-controlled trials and open-label extension studies in adult patients with Parkinson’s disease psychosis, as well as in development programs in adult patients with schizophrenia, major depressive disorder, and dementia-related psychosis. Although pimavanserin pharmacokinetics (PK) and tolerability have been evaluated in adolescent patients with psychiatric disorders, its efficacy and safety have not been evaluated in adolescent or pediatric patients. PK data from varying adult populations (healthy subjects and patients) can be used to predict an appropriate dose for adolescent or pediatric patients. An ideal pediatric dose would achieve the same systemic pimavanserin exposure as pimavanserin 34 mg in adult patients.

By Mona Darwish, Dragana Bugarski-Kirola, David Jaworowicz, Joel Owen, Farah Al Qaraghuli, Alida Barry, Daryl DeKarske, Srdjan Stankovic.

Poster presented at the American College of Neuropsychopharmacology (ANCP) Annual Meeting. December 5 -8, 2021, San Juan, Puerto Rico.