Acadia to take issue with FDA over CRL for Nuplazid sBLA

Shares of US drugmaker Acadia Pharmaceuticals (Nasdaq: ACAD) plunged more than 17% to $21.18 by close of trading Monday, after it revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

The FDA issued a CRL to indicate that it has completed the review of the application and has determined that the sNDA cannot be approved in its present form.

Despite prior agreements with the Division of Psychiatry regarding the pivotal Phase III HARMONY study design targeting a broad DRP patient population analyzed as a single group, the Division, in the CRL, 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, noted Acadia.