The new drug application for Acadia Pharmaceutical’s Nuplazid (pimavanserin) has been accepted by the FDA and granted priority review. As a result, the FDA will take action on the review by May 1, 2016.
If it is approved, Nuplazid would be the first FDA-approved treatment for Parkinson’s disease psychosis (PDP), which affects approximately 40 to 50% of Parkinson’s patients over the course of their disease. Patients with PDP often experience visual hallucinations and delusions that place a significant added burden on their quality of life and that of their caregiver.
“Nuplazid is a first-in-class selective serotonin inverse agonist preferentially targeting 5-HT2A receptors, representing an entirely new pharmacological treatment approach for addressing PDP,” Rajesh Pahwa, MD, director of the Parkinson’s Disease and Movement Disorder Center at the University of Kansas Medical Center, told Neurology Advisor. “Nuplazid has been shown in clinical trials to treat hallucinations and delusions without impairing motor control in patients with PDP.”
With no currently approved treatments for PDP, physicians often “resort to the off-label use of currently available antipsychotics, though use of these drugs often leads to unwanted side effects, including worsening of PD motor symptoms and carry a black box warning,” Dr. Pahwa said.
In a phase 3, randomized, double-blind, placebo-controlled study, pimavanserin was associated with a −5.79 decrease in Parkinson’s disease-adapted scale for assessment of positive symptoms (SAPS-PD) scores compared with −2.73 for placebo (difference −3.06, 95% CI −4.91 to −1.20; P=0·001; Cohen’s d 0·50), with no significant safety concern or worsening of motor function reported.