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Tolerable uncertainty

How Acadia redesigned endpoints to find one sensitive to Nuplazid's benefits

Acadia Pharmaceuticals Inc. may have found a sensitive endpoint for Nuplazid pimavanserin in a condition lacking good measures by adapting a validated but broader scale. Although an FDA advisory committee was uncertain how much real-world benefit was represented for a given amount of improvement on the scale, they thought even a modest benefit would be valuable given the lack of treatments for Parkinson's disease psychosis.

At a March 29 meeting, Psychopharmacologic Drugs Advisory Committee members voted 12-2 that the small molecule serotonin (5-HT2A) receptor inverse agonist's benefits outweighed its risks to treat PDP. Panelists also voted 12-2 that Acadia provided substantial evidence of Nuplazid's efficacy and 11-3 that the company adequately characterized the safety profile.

Roughly half of PD patients may develop PDP, which is characterized by non-motor symptoms including hallucinations and delusions that can be both distressing and debilitating. Patients may disregard their own safety or act out violently if they believe they are in danger.

Acadia sought to develop a

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