With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.
Acadia Pharmaceuticals has resubmitted its supplemental new drug application for Nuplazid (pimavanserin) for the treatment of patients with hallucinations and delusions associated with Alzheimer’s disease psychosis. The resubmission includes additional analyses of two previously conducted studies: HARMONY and Study-019.
The FDA has given the application a target action date of August 4, 2022, and the FDA’s Division of Psychiatry is planning to hold an advisory committee meeting in connection with its review.
“We look forward to working with the division during the course of their review and in preparation for the advisory committee meeting,” Steve Davis, chief executive officer, said in a press release. “With no FDA approved drug to treat Alzheimer’s disease psychosis, the hallucinations and delusions that Alzheimer’s patients endure represent a highly significant unmet need, dramatically altering the lives of both Alzheimer’s patients and their caregivers.”
The agency had issued a complete response letter in April 2021 for this indication, 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.
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.