Benzinga | Apr 5, 2021 07:22AM EDT

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 (NASDAQ: 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.