FDA, Safety

Dismissing critical reports on patient deaths, FDA says safety/effectiveness of Nuplazid holds up under review

Not long after Acadia’s Nuplazid hit the market, green lighted by the FDA despite its own in-house concerns about a possible link to patient deaths, the drug remained a lightning rod for controversy. CNN highlighted more deaths for the approved drug and ProPublica held it up as a prime example of what it viewed as the FDA’s willingness to rush risky drugs to patients without proper vetting.

But after looking over the data and considering its effectiveness, the FDA says there’s no reason to change its bottom line: “The drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis.”

Stamped with a black box safety warning, the agency noted that this drug is headed to a frail population of older Parkinson’s patients who are already facing distinctly high risks of dying. In addition, the safety program built around the drug makes it more likely that the death of a patient taking this therapy will be reported, contributing to the record of hundreds of deaths first noted by the CNN report.

For Acadia, that clean bill of health, so to speak, helped repair much of the damage that’s been done to its stock price. Shares jumped 23% as word spread about the FDA’s verdict.

Regulators did say they found one troubling issue that needs to be addressed by physicians. Nuplazid is sometimes prescribed with other antipsychotic drugs or drugs that can cause QT prolongation, a potential cause of heart rhythm disorder. 

“Based on this observation, FDA reminds health care providers to be aware of the risks described in the prescribing information. FDA also reminds heath care providers that none of the other antipsychotic medications are approved for the treatment of Parkinson’s disease psychosis.”

Barring some unexpected event, the drug’s position on the US market seems assured. As for Acadia, it’s also been forced to rejig its development plans after running into problems with an attempt to prove its effectiveness in Alzheimer’s patients. Researchers changed strategies, looking at the drug’s impact for psychosis among patients suffering from a mix of ailments.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,500+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->