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.”
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.