US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis

Complete Response Letter Requires More Data

 
• By Jessica Merrill
  
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Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.

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Acadia's Nuplazid expansion plans were halted by FDA • Source: Alamy (LAMB / Alamy Stock Photo/Alamy Stock Photo)

The US Food and Drug Administration has dashed ACADIA Pharmaceuticals Inc.'s hopes for a near-term expansion of Nuplazid (pimavanserin) into a broad population of patients with dementia-related psychosis (DRP). Receiving a complete response letter (CRL) wasn't a surprise, given that the company announced a delay in March due to deficiencies in the supplemental new drug application, but the scope of the requests outlined by Acadia on 5 April appear serious and could result in a lengthy delay.

The FDA's issue with the sNDA appears to revolve around the design of the Phase III clinical trial that was...

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