Trevor Hawkins1, Brian D Berman1. 1. Department of Neurology (TH, BDB), University of Colorado Anschutz Medical Campus, Aurora; and Neurology Section (BDB), Denver VA Medical Center, CO.
Abstract
PURPOSE OF REVIEW: In April 2016, the Food and Drug Administration (FDA) approved a first-in-class atypical antipsychotic medication called pimavanserin for the treatment of Parkinson disease psychosis (PDP). We aim to inform readers about its indications, effectiveness, and safety profile. RECENT FINDINGS: Pimavanserin acts as an inverse agonist at serotonin 5-HT2A receptors and has negligible effects on other receptors, thereby avoiding the D2 receptor antagonism that can potentially worsen motor symptoms. Its FDA approval was based primarily on the results of a single randomized, placebo-controlled phase 3 trial. SUMMARY: While pimavanserin appears to be a safe, effective, and well-tolerated therapeutic option for PDP, additional clinical trials and open-label extension studies are needed to determine the long-term safety and efficacy of this promising therapy. In the meantime, prescribers need to be aware of the possible adverse effects of pimavanserin including QT interval prolongation and a potential to cause a paradoxical worsening of symptoms.
PURPOSE OF REVIEW: In April 2016, the Food and Drug Administration (FDA) approved a first-in-class atypical antipsychotic medication called pimavanserin for the treatment of Parkinson disease psychosis (PDP). We aim to inform readers about its indications, effectiveness, and safety profile. RECENT FINDINGS: Pimavanserin acts as an inverse agonist at serotonin 5-HT2A receptors and has negligible effects on other receptors, thereby avoiding the D2 receptor antagonism that can potentially worsen motor symptoms. Its FDA approval was based primarily on the results of a single randomized, placebo-controlled phase 3 trial. SUMMARY: While pimavanserin appears to be a safe, effective, and well-tolerated therapeutic option for PDP, additional clinical trials and open-label extension studies are needed to determine the long-term safety and efficacy of this promising therapy. In the meantime, prescribers need to be aware of the possible adverse effects of pimavanserin including QT interval prolongation and a potential to cause a paradoxical worsening of symptoms.
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