Acadia Pharmaceuticals (ACAD) and its Parkison's psychosis drug Nuplazid is being reviewed by an advisory panel convened by the U.S. Food and Drug Administration today. Follow this live blog for all the action from the panel, including the penultimate voting questions this afternoon.
Nuplazid "minimally improved" hallucinations and delusions caused by Parkinson's disease while also exposing patients to a "substantial safety risk," a U.S. Food and Drug Administration review of the drug concluded on Friday.
Acadia, not surprisingly, views Nuplazid more favorably. The company argues the drug provides a "clinically meaningful benefit" with "robust improvements" across different measures of psychosis in Parkinson's patients. Study results also show Nuplazid has an "acceptable tolerability profile" with "well characterized safety risks," Acadia said in its own brief Friday.
Tuesday's panel of outside experts are meeting at FDA headquarters to hash out the conflicting characterizations of Nuplazid. At the end the day-long meeting, the experts will be asked to vote, yes or no, whether Nuplazid should be approved for the treatment of psychosis in Parkinson's patients.
The outcome of the vote is hugely important to Acadia. An affirmative decision would most likely compel FDA to approve Nuplazid by its decision date of May 1.