ACADIA Pharmaceuticals Inc. is complaining that the US Food and Drug Administration has moved the goal posts for expanding the indication 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