Acadia Pharma Receives CRL For SNDA Of Pimavanserin On Dementia-Related Psychosis; Stock Plunges

Acadia Pharmaceuticals Inc. (ACAD) said Monday that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its supplemental New Drug Application or sNDA for NUPLAZID or pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis or DRP.

In Monday pre-market trade, ACAD was trading at $22.00 down $3.59 or 14.03 percent.

The FDA has determined that the application cannot be approved in its present form.

The Division of Psychiatry cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

The Division also stated in the CRL that it considers the Phase 2 Alzheimer's disease psychosis study -019, a supportive study in the sNDA filing, to not be adequate and well controlled, citing that it was a single center study with no type I error control of secondary endpoints in which certain protocol deviations occurred.

The company believes the observations impact neither the positive results on the study's primary endpoint, nor the study's overall conclusions of efficacy.

There were no safety issues or concerns raised in the CRL.

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