The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12-2 on March 29, 2016 that the benefits of Nuplazid for the treatment of Parkinson’s Disease Psychosis outweigh the associated risks. The Advisory Committee provides the FDA with independent recommendations from expert; the FDA is not bound by the Committee’s recommendations but considers the Committee’s finding during the new drug review process.
Updated June 2016 Cost Of Nuplazid
The cost of Nuplazid (pimavanserin) has been announced by Acadia. A 30 day supply is priced at $1950.00 per month; $23,400 per year.
Why Nuplazid Could Be A Game Changer
The National Parkinson Foundation estimates four to six million people have Parkinson’s Disease throughout the world; one million people in the United Stated have Parkinson’s. The Foundation estimates approximately 40 percent of Parkinson’s patients also develop Parkinson’s Disease Psychosis (PDP) which elicits hallucinations and delusions along with the medical challenges Parkinson’s presents for the patient.
Frequently off label, black box warning drugs are prescribed to treat PDP. The black box drugs are strong antipsychotic drugs which have their own set of possible side effects. The hope for Nuplazid is to be a drug which treats PDP, but without the possible serious side effects of black box warning drugs; this could be a game changer for the quality of life of the patient, the caregivers and the family.
If you are interested in reading further how Nuplazid can treat PDP, click here for additional information.
Fast Tracking And Priority Review FDA
Nuplazid remains in the priority review process at the FDA. A decision is expected by May 1, 2016. Priority review status by the FDA fast tracks promising drugs through the approval process; Nuplazid entered the FDA approval process in November 2015.
Acadia Stock Price and Nuplazid
Prior to the FDA Advisory Committee meeting on March 29, 2016 trading was halted on Acadia stock. While this is not indicative of whether Nuplazid will be approved by the FDA, it is indicative of the possible financial impact the approval of FDA would have for Acadia. Those who track pharmaceutical companies and their stock for possible purchase are used to the incline and decline of stock prices as a new drug enters the trial and approval process and then winds its’ way through the FDA approval process.
From my own perspective, very few prospective drugs elicit a halt trading order. Trading for the ACAD stock was halted until after the FDA Review Advisory Committee issued its’ vote on March 29, 2016.