Combined statistics from the nonprofit health care organization Institute for Safe Medication Practices (ISMP) as well as the FDA Averse Events Reporting System (FAERS) indicate there has been 741 adverse events (AEs) reported as deaths in patients treated with Nuplazid, as of Tuesday.
Pimavanserin is an antagonist at serotonin 5-HT 2A receptor, with a novel mechanism that allows it to behave as a selective inverse agonist of the receptor without significant affinity or activity at dopamine receptors — contrary to the mechanism of other receptors. When it was approved to treat hallucinations and delusions associated with psychosis experienced by patients, the FDA Center for Drug Evaluation and Research’s Director of the Division of Psychiatry Products Mitchell Mathis, MD, said Nuplazid “represents an important treatment” for patients of PD who experience such symptoms.
It was approved on the strength of a six-week clinical trial involving 199 patients, in which pimavanserin showed superior efficacy in decreasing hallucination and delusion frequency and/or severity in PD patients — without worsening primary motor symptoms.
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