Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis, could struggle to gain a new nod in Alzheimer’s after agency briefing notes revealed doubts over the developer’s submission.
Pimavanserin is a selective serotonin inverse agonist and antagonist, and Acadia Pharmaceuticals (Nasdaq: ACAD) wants to broaden its use to include Alzheimer's disease psychosis.
It is the second time trying for Acadia to expand the indication for pimavanserin, which in April 2021 received a Complete Response Letter (CRL) from the US Food and Drug Administration in relation to its application for dementia-related psychosis.
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