FDA Schedules Advisory Committee for Nuplazid in Alzheimer’s Psychosis


The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.

The FDA’s Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022, to review Acadia Pharmaceuticals’ resubmitted supplemental new drug application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis. The target action date for the application is August 4, 2022.

The resubmission includes additional analyses of two previously conducted studies: HARMONY and Study-019.

The agency had issued a complete response letter in April 2021 for this therapy to treat dementia-related psychosis, saying that in the HARMONY study there was a lack of statistical significance in some of the subgroups of patients with dementia. In addition, FDA officials said there was a lack of sufficient number of patients in dementia subtypes. Regulatory authorities also said that it considered the phase 2 Study-019 not adequate because it was not well controlled and because protocol deviations occurred. No safety issues were raised in the response letter.

Alzheimer’s affects about 45 million worldwide, and psychosis has an incidence of about 10% per year, according a review published in Current Neurology and Neuroscience Reports. The prevalence of psychosis is about 40% but studies have shown a lower prevalence in patients with mild Alzheimer’s disease. Psychotic symptoms can last for at least a year in two-thirds of patients who experience them, but investigators say patients often have a pattern of remission and recurrence of such symptoms.

Steve Davis

Steve Davis

“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. 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,” CEO Steve Davis said in a press release.

Nuplazid is a selective serotonin inverse agonist and antagonist targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. The FDA approved Nuplazid in April 2016 for the treatment of patients with hallucinations and delusions associated with Parkinson’s disease psychosis. It is the only therapy approved for this indication.

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