The drug’s developer announced that the FDA has made 2 clarifying revisions.
The US Food & Drug Administration (FDA) has made 2 updates to the packaging label for an approved treatment for Parkinson disease psychosis.
The revisions to the packing label provide some clarification about use of pimavanserin (Nuplazid®) in its approved indication for Parkinson disease psychosis. There have been 2 changes. The first change was to language in the Clinical Studies section of the drug’s Boxed Warning, which has been revised to include reiteration that the phase 3 study supporting the FDA’s decision to approve pimavanserin included patients with delusions and hallucinations related to Parkinson disease, either with or without dementia.1
The second change was to Boxed Warning language clarifying that pimavanserin is FDA-approved to treat patients who have both dementia and Parkinson disease-related delusions and hallucinations. The FDA noted that there have been no revisions to the risk information in the drug’s Boxed Warning.1
Affecting an estimated 1 million individuals in the United States, Parkinson disease may involve a variety of both motor and non-motor symptoms including delusions and hallucinations. About 50% of individuals with Parkinson disease experience delusions and/or hallucinations at some point over the course of the disease,1 and up to 80% of individuals with Parkinson disease will eventually develop dementia.2
Given the prevalence of delusions and hallucinations in individuals with Parkinson disease and the connections between Parkinson disease and dementia, the Boxed Warning revisions stating that pimavanserin is approved to treat patients with both Parkinson disease and dementia can aid clinicians in the treatment process.
“This update makes it clear that Nuplazid can be prescribed to treat patients with Parkinson’s disease psychosis, with or without dementia,” said Jeffrey Cummings, MD, ScD, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, in a press release. “As a prescriber, I believe that this clarification to the Boxed Warning language will help health care providers better identify appropriate candidates with Parkinson’s disease psychosis for treatment with Nuplazid.”
Approved by the FDA in 2016, pimavanserin is a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors, which are thought to be important in neuropsychiatric disorders.1 It is the first FDA-approved drug to treat delusions and hallucinations associated with Parkinson disease.3
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, MD, then director of the Division of Psychiatry Products in the FDA Center for Drug Evaluation and Research, in the news release announcing the drug’s approval. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”2
Acadia Pharmaceuticals, developer of pimavanserin, has announced that it is also currently working on developing the drug for other neuropsychiatric conditions, including negative symptoms of schizophrenia.4,5
Its ADVANCE-2 study of pimavanserin for the treatment of predominant negative symptoms of schizophrenia, with topline results of the Phase 3 ADVANCE-2 trial anticipated in the first quarter of 2024.4
1. Acadia Pharmaceuticals announces label update for NUPLAZID (pimavanserin). Acadia Pharmaceuticals. News release. September 18, 2023. Accessed September 19, 2023. https://acadia.com/media/news-releases/acadia-pharmaceuticals-announces-label-update-for-nuplazid-pimavanserin/
2. Parkinson’s disease dementia. University of California San Francisco Weill Institute for Neurosciences, Memory and Aging Center. Accessed September 19, 2023. https://memory.ucsf.edu/dementia/parkinsons/parkinson-disease-dementia#:~:text=Up%20to%2080%25%20of%20people,dementia%20is%20about%2010%20years.
3. FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease. US Food & Drug Administration. News release. April 29, 2016. Accessed September 19, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-hallucinations-and-delusions-associated-parkinsons-disease#:~:text=The%20U.S.%20Food%20and%20Drug,some%20people%20with%20Parkinson's%20disease.
4. Product pipeline. Acadia Pharmaceuticals. Accessed September 19, 2023. https://acadia.com/pipeline/
5. Meglio M. FDA updates label for psychosis medication pimavanserin. Neurology Live. September 19, 2023. Accessed September 19, 2023. https://www.neurologylive.com/view/fda-updates-label-psychosis-medication-pimavanserin