FDA Asks For Additional Study For Acadia's Pimavanserin In Alzheimer's-Associated Delusions

The FDA has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals Inc (NASDAQ:ACAD) regarding its supplemental marketing application for pimavanserin in hallucinations and delusions associated with Alzheimer's disease psychosis (ADP).
The CRL recommended that Acadia conduct an additional trial in ADP.
The advisory committee voted 9-3 that Acadia's pimavanserin doesn't appear effective in treating ADP patients.
While the FDA stated that Study 019 demonstrated a statistically significant treatment effect on its primary endpoint, they concluded that there are limitations in the interpretability of the 019 results.
Also Read: Analysts Try To See Beyond Acadia's Alzheimer's Disease Psychosis.
The FDA also stated that the positive treatment effect of pimavanserin on dementia-related psychosis in Study 045 (HARMONY) appeared to be driven by positive results in the Parkinson's disease dementia (PDD) subgroup.
The agency stated that PDD is subsumed within the currently approved Nuplazid Parkinson's disease psychosis (PDP) indication. Up to 50% of PDP patients have dementia.
Nuplazid was approved in the U.S. in 2016 and is the first and only treatment for hallucinations and delusions associated with PDP.
Price Action: ACAD shares are down 3.01% at $15.15 during the premarket session on the last check Friday.