FDA endorses Acadia's Nuplazid after review of deaths tied to drug

The FDA endorsed the safety of Acadia's Nuplazid after another review. (FDA)

Acadia faced a safety controversy earlier this year when a CNN report outlined hundreds of deaths for patients on Nuplazid and the FDA started a safety review of the drug. Now, the agency reports that Nuplazid's label adequately describes risks, and that the med's benefits outweigh its risks. 

After reviewing postmarketing deaths and adverse events reports for patients on Nuplazid, the FDA said it “did not identify any new or unexpected safety findings with Nuplazid, or findings that are inconsistent with the established safety profile currently described in the drug label.” 

RELATED: FDA strikes up review of Acadia's Nuplazid after report highlights hundreds of deaths


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The FDA started its review amid a controversy for Acadia, in part due to a CNN report that found hundreds of patients have died after receiving the drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis. At the time, Acadia said it stood by Nuplazid’s safety. The drug won approval in April 2016 with a black-box warning. Nuplazid is the only drug approved to treat hallucinations and delusions associated with PDP.

In a statement Thursday, Acadia CEO Steve Davis said nothing is “more important to Acadia than the wellbeing of the patients who use Nuplazid.” 

“We are very pleased with the FDA’s clear statement reaffirming NUPLAZID’s positive benefit-risk profile,” he added.

RELATED: FDA's internal review of Acadia's Parkinson's drug raises safety, benefit concerns   

The company's shares, which tumbled earlier this year amid the safety controversy, jumped about 25% after the FDA posted the conclusion of its review.
The CNN report wasn’t the first time Nuplazid faced scrutiny over safety. Before the med’s approval in 2016, internal FDA reviewers flagged questions, and an independent panel of experts raised concerns about the drug's data during the review process. Still, many panelists said the drug would treat patients with no alternatives who would be willing to take the risks associated with the therapy. 

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