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Future Of Acadia’s Nuplazid In Alzheimer’s Psychosis Unclear After CRL

 
• By Alaric DeArment

An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead. 

Acadia has been asked to conduct another Phase III study of Nuplazid in ADP, but will it? • Source: Shutterstock

The complete response letter (CRL) that ACADIA Pharmaceuticals Inc. got from the US Food and Drug Administration for Nuplazid (pimavanserin) in Alzheimer’s disease psychosis (ADP) did not come as a surprise, given the negative FDA advisory committee vote for the drug in June. But it’s still a significant setback for the company, and it remains uncertain whether it will continue pursuing the indication in another trial.

Acadia announced the CRL, which calls for an additional trial, on 4 August. The agency said in the letter that while one of the studies that the company submitted for its new drug application, the Phase II Study 019, showed a statistically significant treatment effect on the primary endpoint, there were limitations in the results’ interpretability

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