FDA
19th April 2016

Nuplazid Gains Support from the FDA’s Psychopharmacologic Drugs Advisory Committee

On March 29th, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease-related psychosis. Nuplazid (Acadia Pharmaceuticals) is a selective serotonin inverse agonist that helps to reduce hallucinations and other psychotic symptoms in some patients with Parkinson’s disease (PD), without affecting motor symptoms.

Nuplazid Gains Support from the FDA’s Psychopharmacologic Drugs Advisory Committee

On March 29th, the Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor of Nuplazid (pimavanserin) for the treatment of Parkinson’s disease-related psychosis. Nuplazid (Acadia Pharmaceuticals) is a selective serotonin inverse agonist that helps to reduce hallucinations and other psychotic symptoms in some patients with Parkinson’s disease (PD), without affecting motor symptoms.

For the evaluation of Nuplazid’s efficacy, safety and risk/benefit, PDAC relied primarily on evidence from a positive 6-week phase III trial (ACP-103-020), which included 199 patients with Parkinson’s disease psychosis (PDP). In addition, Acadia submitted results of three other randomized controlled trials. The committee voted 12 to 2 in favor of the product’s efficacy, 11 to 3 in favor of the drug’s safety, and 12 to 2 that the drug’s benefits outweigh its potential risks.

The review also included a public hearing session during which caregivers and loved ones shared personal accounts of patients’ stories and conveyed the poor quality of life associated with PDP. Despite Nuplazid’s promising trial results and public hearing testimonies, some committee members had concerns around the potential increased risk for severe adverse events, including death. However, the committee acknowledged that PDP can affect up to 40% of patients with PD at some point in their illness, and there are currently no FDA-approved drugs for the condition.

Committee Chair, David A. Brent, MD, academic chief, Division of Child and Adolescent Psychiatry, University of Pittsburgh School of Medicine stated, “Although we would have liked to have seen a bigger trial and a stronger effect, in the context of this disease and the lack of other readily available treatments that are easy to use, this represents a step forward.”

 

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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