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news.The US Food and Drug Administration's (FDA) psychopharmacologic drugs advisory committee will review data included in Acadia Pharmaceuticals' new drug application (NDA) for Nuplazid (pimavanserin) to treat psychosis associated with Parkinson’s disease.
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The meeting will be held on 29th March. Last November, the FDA classified the Nuplazid NDA as having priority review status with a target prescription drug user fee act (PDUFA) action date of 1st May this year.
Nuplazid is a new class of non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist, preferentially targeting 5-HT2A receptors that are believed to play a key role in psychosis.
The drug is administered orally once-a-day. Acadia has reported positive phase III trial results with Nuplazid in Parkinson’s disease psychosis.
The company discovered Nuplazid and holds global rights to the chemical entity. Acadia said the drug’s safety and efficacy have not been fully assessed by any regulatory authority.
Acadia president and CEO Steve Davis said: "Parkinson’s disease psychosis is a debilitating condition for which there are no FDA-approved treatment options available to patients.
"We look forward to discussing our data from the Nuplazid clinical program with the members of the Committee."
Approximately one million people in the US and from four to six million people globally suffer from Parkinson’s disease, according to the National Parkinson Foundation.
About 40% of those people are estimated to have Parkinson’s disease psychosis, which is a serious mental disorder characterized by thinking and emotions that are so impaired.
Image: Nuplazid is a new class of non-dopaminergic antipsychotic that acts as an selective serotonin inverse agonist. Photo: courtesy of Mister GC/FreeDigitalPhotos.net.