Acadia Pharmaceuticals Inc on Thursday announced that the U.S. Food and Drug Administration (USFDA) has declined to approve the expanded use of its antipsychotic drug for treating psychosis related to Alzheimer’s disease. The drug is sold under the brand name Nuplazid.
According to a report by the news agency Reuters, the health regulator concluded there were limitations in the interpretability of Acadia’s antipsychotic drug study and an additional study would be required.
Meanwhile, the U.S. regulator’s decision comes roughly a month after its panel of outside advisors voted 9-3 that available data does not support the conclusion that the drug, pimavanserin, was effective for the treatment of hallucinations and delusions in Alzheimer’s disease.
“We are disappointed with this outcome. The treatment of Alzheimer’s disease psychosis continues to be an area of high unmet need, for which there is no approved therapy,” Acadia Chief Executive Officer Steve Davis said as quoted by news agency Reuters.
This was Acadia’s second attempt to secure approval for expanded use of the drug. In April 2021, the FDA told Acadia its clinical trial data was not sufficient to support the approval of pimavanserin in patients with dementia-related psychosis.
The company resubmitted its application in February with a focus on Alzheimer’s patients. The drug is already approved for a similar indication in patients with Parkinson’s disease and brought in sales of $484 million last year.
(With inputs from Reuters)