The U.S. Food and Drug Administration didn’t find new safety concerns after reexamining Acadia Pharmaceutical’s drug to treat hallucinations and delusions caused by Parkinson’s disease.
The Sept. 20 announcement, which also stated that the benefits of Acadia’s Nuplazid still outweigh risks, caused the company’s stock to spike.
In April, the FDA said it was taking another look at Nuplazid, which the agency had previously approved. During the review it was recommended patients keep taking the drug.
A CNN report this spring drew attention to a November publication from the Institute for Safe Medication Practices, which noted reports of more than 200 deaths of patients who had been using the drug through March 2017.
But the FDA on Sept. 20 noted those with Parkinson’s have a higher mortality rate than the general population. In addition, Nuplazid was distributed through a specialty pharmacy network, increasing the likelihood that deaths would be reported to the manufacturer.
“After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients,” said the FDA’s statement, noting that Nuplazid is the only approved treatment for Parkinson’s psychosis.
Acadia’s stock closed at $19.11, up more than 26 percent from the day’s open.