Acadia Pharmaceuticals faced a safety controversy last year after a CNN report detailed hundreds of deaths for patients on its Nuplazid drug for Parkinson’s patients. Now, the company is facing a different type of scrutiny: a Justice Department probe into its marketing practices.
In a securities filing, Acadia disclosed that the Justice Department in September demanded information and documents related to its Nuplazid marketing. The company said it’s cooperating with the request, but responding to the probe “will require considerable resources.”
The disclosure came after Acadia defended Nuplazid’s safety and benefits last year. In an April report, CNN highlighted hundreds of deaths among patients taking the drug, and investors sent shares down sharply.
Acadia responded that the drug is the only currently approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis. The drug fills an “important and previously unmet need and offers hope to those with PDP and the people who care for them,” the company said at the time.
In a Monday interview with FiercePharma, Acadia CEO Steve Davis said his company is “really committed to a culture of compliance” and stands behind its physician interactions. He said Acadia is cooperating with the DOJ’s request.
Commenting generally on the Nuplazid launch, Davis said Acadia has been working to raise awareness of the condition. No drug had ever been approved in Parkinson’s disease psychosis before Nuplazid, he said. Further, Acadia’s drug has a different mechanism of action than other antipsychotic medicines.
“We thought there was a lot that we needed to accomplish,” he said. “We have made some very significant inroads in elevating the awareness of PDP and helping the medical community to understand some of the dynamics” in the disease.
Davis also stressed that the FDA has twice looked at Nuplazid’s safety and efficacy. Shortly after the CNN report, the agency said it was once again reviewing the drug; the agency later said it found no new risks. Nuplazid carries a black-box warning for an increased risk of death in elderly patients.
Editor’s note: This story was updated with comments from Acadia CEO Steve Davis.