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Acadia’s Nuplazid: US FDA Panel Will Focus On Efficacy For Alzheimer’s Disease Psychosis

 
• By Sue Sutter

Agency questions clinical significance of change in primary efficacy endpoint measured in one study and raises doubts about numerous exploratory analyses for a second study aimed at explaining why Alzheimer’s patient subgroup appeared to derive less benefit than other types of dementia patients.

Alzheimers brain images
Acadia is seeking to add an Alzheimer's disease psychosis treatment indication to Nuplazid's label. • Source: Shutterstock

The US Food and Drug Administration is raising a host of questions about adequacy of the efficacy evidence for Acadia Pharmaceuticals Inc.’s Nuplazid (pimavanserin) in treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).

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