ACADIA Pharmaceuticals accounced that the FDA Psychopharmacologic Drugs Advisory Committee voted that the benefits of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease-related psychosis outweighed the risks of the drug.
Nuplazid is a selective serotonin inverse agonist and, if approved, will establish a new and distinctly different pharmacological approach to treat psychosis. The drug has successfully completed a pivotal Phase 3 trial in Parkinson’s disease psychosis.
The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that produce certain human drugs and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
The PDUFA action date for completion of FDA review of the Nuplazid New Drug Application (NDA) is May 1. The FDA has granted Breakthrough Therapy designation to Nuplazid for the treatment of Parkinson’s disease psychosis.
“We are very encouraged by the committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid,” Steve Davis, ACADIA’s president and CEO, said in a press release. “If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.”
The advisory committee provides the FDA with independent expert recommendations on the efficacy and safety of potential novel drugs.
One million people suffer from Parkinson’s disease in the United States. Parkinson’s disease psychosis (PDP) is a debilitating disorder that occurs in 40 percent of all Parkinson’s patients. There is currently no FDA-approved therapy to treat PDP in the U.S.
PDP can occur at any stage of the illness, and is a particularly important issue for patients who are in the later stages of Parkinson’s and have been chronically treated with anti-Parkinson’s medications. The exact pathophysiology of Parkinson’s disease-related psychosis remains a mystery. Neurochemical imbalances, sleep disturbances, and visual processing abnormalities in Parkinson’s have all been implicated in its pathogenesis.