US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis

Complete Response Letter Requires More Data

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.

stop sign
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 the basis for seeking approval for treatment of hallucinations and delusions in patients with DRP – and that could be very bad news for Acadia

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