Drugs

FDA ‘Complete Response’ on Nuplazid sNDA

FDA has issued Acadia Pharmaceuticals a complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis (DRP), indicating that the submission cannot be approved in its present form.

“Despite prior agreements with the [FDA] Division of Psychiatry regarding the pivotal Phase 3 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,” the company says.

The HARMONY study, Acadia contends, met its prespecified primary and secondary endpoints with “robust and persuasive clinical and statistical superiority of pimavanserin over placebo,” which it describes as a prospectively agreed prerequisite for the DRP indication. “Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements,” it says.

The FDA division also told the company that it considers a Phase 2 Alzheimer’s disease psychosis study, a supportive study in the sNDA filing, to not be adequate and well controlled because it was a single center study with no Type 1 error control of secondary endpoints in which certain protocol deviations occurred. Acadia adds that these observations “impact neither the positive results on the study’s primary endpoint, nor the study’s overall conclusions of efficacy.” No safety issues or concerns were raised in the letter, the company says.

Nuplazid was approved in the U.S. in 2016 as the first treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. It is described as a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors, which are believed to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders.

Acadia plans to request a Type A meeting to work with FDA to address the letter’s concerns and determine a path forward for the drug.

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