FDA Hits Acadia With Complete Response Letter Over Nuplazid

The FDA issued a Complete Response Letter (CRL) to San Diego, Calif.-based Acadia Pharmaceuticals for its supplemental New Drug Application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis.

According to Acadia, the agency cited a lack of statistical significance in some of the subgroups of dementia in the drug’s phase 3 trial and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.

The CRL followed a March 8 FDA notification to the company of deficiencies regarding Nuplazid. According to Acadia at the time, the FDA “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time,” but did not tell the company what those deficiencies were.