Tolerable uncertainty

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...