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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