U.S. Food and Drug Administration staff members said on Friday Acadia Pharmaceuticals Inc's drug to treat psychosis associated with Parkinson's disease was an effective treatment for the condition.
The drug, Nuplazid, is a new chemical compound and could be the first drug specifically approved in the United States for Parkinson's disease psychosis (PDP). (1.usa.gov/1PuYUCe)
Parkinson's disease is typically associated with impaired motor function.
However non-motor symptoms, such as psychosis characterized by hallucinations and delusions, occur in about 25 percent of Parkinson's patients, said Alan Carr, an analyst with investment banking and asset management firm Needham & Co.
This translates into an addressable population of 250,000 for the drug in the United States, according to Carr.
Existing antipsychotics, including Quetiapine, Clozapine, Risperidone and Zyprexa, are not labeled for use in PDP.
They offer limited effectiveness and are poorly tolerated, which is underscored by a black box warning for increased mortality in elderly patients.
A black box warning is the strongest warning imposed by the FDA, and is designed to call attention to serious or life-threatening risks.
FDA staff members on Friday did not recommend such a warning for Nuplazid.
Nuplazid was granted the FDA's breakthrough therapy status in 2014 on the basis of a late-stage study that showed it reduced psychosis symptoms, with a relatively clean safety profile. (bit.ly/1PuZPCO)
FDA scientists released their report ahead of a meeting on Tuesday of an independent medical advisory panel. While the FDA is not obligated to follow the panel's recommendations, it typically does so. The FDA is slated to decide on the treatment's approval by May 1.
Nuplazid will likely win approval and be adopted as the treatment of choice, some industry analysts have said. (Reporting by Natalie Grover and Arathy S Nair in Bengaluru; Editing by Chizu Nomiyama and W Simon)
http://www.reuters.com/article/acadia-pharm-fda-idUSL2N16X0AU
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