ACADIA Pharmaceuticals Inc.’s (ACAD) Nuplazid, proposed for expanded use in treating hallucinations and delusions associated with Alzheimer’s disease psychosis, is slated to be reviewed by an FDA panel on June 17, 2022.Currently, there are no FDA-approved treatments for Alzheimer’s disease psychosis. However, atypical antipsychotic agents like Aripiprazole are used off-label for treating this condition.The final FDA decision on the expanded use of Nuplazid is expected on August 4, 2022.Nuplazid, known generically as Pimavanserin, was approved in the U.S. in April 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.Last April, the FDA had declined to approve Nuplazid for the treatment of dementia-related psychosis due to a “lack of statistical significance in some of the subgroups of dementia and insufficient numbers of patients with certain less common dementia subtypes”.It remains to be seen if Nuplazid passes the regulatory muster the second time around.The drug had notched up annual sales of $484.1 million in 2021, a 10% increase over 2020.ACAD closed Thursday’s (May 26, 2022) trading at $16.23.