Acadia turned back by FDA on second attempt to get psychosis drug approved

For the second time in two years, the Food and Drug Administration has rejected an attempt by Acadia Pharmaceuticals to expand approval of its drug for Parkinson’s disease psychosis into a broader group of patients.

Late on Thursday evening, Acadia revealed the FDA had issued a so-called complete response letter for its application, which sought clearance for the company’s drug pimavanserin as a treatment for hallucinations and delusions associated with Alzheimer’s disease. The drug is already approved for Parkinson’s patients with hallucinations and delusions, for which it’s sold as Nuplazid.

In a statement, Acadia said the FDA recommended the company conduct another trial of pimavanserin in Alzheimer’s patients. According to the company, the agency took issue with results from one study that Acadia submitted, and found the treatment effect observed in another was driven by patients with Parkinson’s who are already included in pimavanserin’s approved indication.

“We are disappointed with this outcome,” Acadia CEO Steve Davis said in the company’s statement, which did not indicate whether Acadia would pursue the additional study requested by the FDA.

The FDA’s rejection follows a vote by independent advisers convened by the agency to review Acadia’s application. In June, the advisory committee voted 9-3 that Acadia’s results didn’t show pimavanserin to be effective at treating hallucinations and delusions in Alzheimer’s patients.

Ahead of that meeting, FDA staff had laid out several concerns with Acadia’s data and the company’s conclusions.

For Acadia, the rejection is a bit of deja vu. Last April, the FDA rejected its application for approval of pimavanserin in the broader indication of dementia-related psychosis. In an April 2021 conference call, Davis accused the FDA of moving the goalposts on an approval, raising concerns late in the review process.

“We clearly strongly disagree with how the division executed the review process of our [application],” Davis said then.

But the company tried again, narrowing its application to seek approval of pimavanserin only in Alzheimer’s disease psychosis, for which the FDA has again rejected the drug.

Acadia executives will likely be pressed by analysts on their plans moving forward on a second quarter earnings call that’s currently scheduled for August 8.

Between January and March, sales of Nuplazid for Parkinson’s disease psychosis reached $116 million, an increase of 8% compared to the same period last year.

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