Acadia's Parkinson's Drug Hit With Critical FDA Review Ahead of Tuesday Panel

March 28, 2016

By Adam Feuerstein

Nuplazid, a drug developed by Acadia Pharmaceuticals(ACAD - Get Report) , "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.

On Tuesday, a panel of outside experts selected by the FDA will meet at the agency's Silver Spring, Md., campus 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 the FDA to approve Nuplazid by its decision date of May 1.

And if approved, Nuplazid could deliver peak sales in Parkinson's exceeding $1 billion, according to some generous analyst forecasts. (The company is also developing the drug to treat psychosis associated with other neurological diseases, including Alzheimer's.)

http://health.einnews.com/article/318615580/VkTu8WzffM21HUko