Relationship between pimavanserin exposure and psychosis relapse in patients with dementia-related psychosis: clinical results and modeling analysis from the phase 3 HARMONY study

Authors: Darwish M, Foff EP, Jaworowicz DJ, Passarell JA, Forman M, Owen JS, Stankovic S
Conference: American College of Neuropsychopharmacology
Keywords: Dementia-related Psychosis, Phase 3 HARMONY Study, pimavanserin
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Dementia-related psychosis impacts more than 2.4 million patients;1-5 however, there are no US FDA-approved therapies. Pimavanserin is being investigated for the treatment of hallucinations and delusions associated with dementia-related psychosis. Exposure–response (E–R) analyses to assess the relationship between drug exposure and efficacy and/or safety are increasingly considered an integral part of clinical drug development.