The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of Nuplazid outweighed the risks of treatment.
The FDA will make its own decision on whether to approve the drug by 1 May 2016. The agency designated Nuplazid to treat Parkinson’s disease psychosis as a breakthrough therapy.
Acadia Pharmaceuticals president and CEO Steve Davis said: "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.
"If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease."
Nuplazid is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that play an key role in psychosis.
The Nuplazid new drug application (NDA) is currently under review by the FDA. If approved, Nuplazid would be taken once a day (34 mg).
In a pivotal Phase III clinical trial, Nuplazid demonstrated a highly significant reduction in psychosis, when compared to placebo. It was the primary endpoint of the study.
Nuplazid also met the key secondary endpoint for motoric tolerability.
Acadia discovered Nuplazid and holds global rights to the new chemical entity. The drug’s safety and efficacy has not been fully evaluated by any regulatory authority.
Image: Last November, the FDA classified the Nuplazid NDA as having priority review status with a target prescription drug user fee act action date of 1 May 2016. Photo: courtesy of Mister GC/FreeDigitalPhotos.net.