Today Acadia Pharmaceuticals (ACAD) announced that it had received FDA priority Review for its Parkinson’s drug NUPLAZID. The FDA has accepted the NDA and now the FDA set a Prescription Drug User Fee Act – PDUFA – for May 1, 2016. Priority review is given to drugs that provide a treatment where no other therapy exists. 

With Priority Review, companies have their drugs reviewed by the FDA many months before others. This means that NUPLAZID will be reviewed 6 months from now instead of 10 months. The faster review time provides the company an opportunity for releasing the drug earlier on the market. Currently there is no FDA approved therapy for Parkinson’s Disease Psychosis, therefore an approval would indicate a big market opportunity for the company. 

As noted above Parkinson’s Disease Psychosis is the approval indication Acadia is looking for. There are a total of one million people in the United States, and four to six million people worldwide with Parkinson’s Disease. Of those approximately 40% have Parkinson’s Disease Psychosis. Parkinson’s Disease Psychosis is classified as Parkinson’s Patients who hallucinations, delusions, caregiver burden, and reduced quality of life. Yesterday Shares of Acadia closed up 15%.