FDA to reconvene on treatment for Alzheimer’s psychosis in June

The FDA announced it will review a resubmitted supplemental new drug application for Nuplazid for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.

Nuplazid (pimavanserin, Acadia Pharmaceuticals) is a selective serotonin inverse agonist and antagonist that targets 5-HT_2A receptors, which are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine, histamine, muscarinic or adrenergic receptors.

The FDA will meet June 17 to review the application.

“We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for [Alzheimer’s disease psychosis] at the upcoming advisory committee meeting,” Stephen R. Davis, CEO of Acadia Pharmaceuticals, said in a released statement.

Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease in 2016, under the Nuplazid brand name. Nuplazid is not approved for Alzheimer’s disease psychosis. Currently, Acadia is developing pimavanserin for the treatment of other neuropsychiatric conditions.

“The hallucinations and delusions that Alzheimer’s patients endure represent one of the most significant burdens in this community, and one of the leading reasons for long-term care placement,” Davis said. “There are no FDA-approved treatments for this critical public health need. Off-label use of multi-receptor acting antipsychotics with marginal efficacy and significant safety concerns can lead to poor patient outcomes, including worsening of cognition and motor function.”