The U.S. Food and Drug Administration (FDA) granted priority review of Acadia Pharmaceuticals' new drug application (NDA) for Nuplazid (pimavanserin) that is intended to treat Parkinson's disease psychosis on Monday.
If approved, Nuplazid would become the first FDA-approved treatment for psychosis in patients with Parkinson's disease. The FDA is expected to make a decision by May 1, 2016.
Psychosis affects approximately 40 percent of patients with Parkinson's disease and causes them to experience hallucinations and delusions. The condition results in reduced quality of life for the patient and increased strain on their caregivers.
Nuplazid, taken orally once a day, was given a breakthrough therapy designation by the FDA last year.
Nuplazid has shown statistically significant efficacy in clinical trials with regards to the treatment of Parkinson's disease psychosis. Acting as a selective serotonin inverse agonist, the drug works by blocking serotonin receptors which stops symptoms of psychosis.
“The FDA priority review designation underscores the potential for Nuplazid to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” Acadia President and CEO Steve Davis said. “We look forward to working with the FDA during the review.”