FDA's Thinking On New Psychiatric Endpoints: What Does Brintellix CRL Portend For Nuplazid?

FDA deviated from its advisory committee's recommendation on the first cognitive function claim for an antidepressant when it issued a complete response letter for Brintellix. The decision could signal trouble for Acadia's Nuplazid for Parkinson's psychosis, which also relies on a new psychiatric endpoint.

FDA's complete response action on a cognitive function claim for Takeda Pharmaceutical Co. Ltd. and H. Lundbeck AS's antidepressant Brintellix could bode poorly for Acadia Pharmaceuticals Inc.'s Nuplazid, which is in a similar position of trying to gain approval based on a novel psychiatric endpoint.

Both drugs have received advisory committee support, but the March 29 complete response letter for Brintellix is a reminder that...