Acadia Stock Drops After FDA CRL For Pimavanserin Application In Hallucinations and Dementia-Related Psychosis

The FDA has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals Inc ACAD regarding its supplemental marketing application (for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).
In the CRL, Psychiatry's division cited a lack of statistical significance in some subgroups of dementia and insufficient numbers of patients with specific less common dementia subtypes.
In 2019, the company presented topline data from the DRP HARMONY study.
Pimavanserin met the study's primary endpoint and was stopped at the pre-planned interim analysis by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo.
Additionally, pimavanserin met the key secondary endpoint by significantly reducing the risk of discontinuation for any reason by 2.2 fold.
Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements.
The division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study for filing, not to be adequate and well-controlled.
It stated that the study was a single-center study with no type I error control of secondary endpoints in which certain protocol deviations occurred.
There were no safety issues or concerns raised in the CRL.
"We will immediately request a Type A meeting to work with the FDA to address the CRL," said Steve Davis, CEO of Acadia.
Price Action: ACAD shares dropped 15.2% at $21.87 in the premarket session on the last check Monday.

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