- Analyses indicate ongoing need for approved treatments with favorable benefit-risk profile for treating patients with dementia-related hallucinations and delusions

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that three data presentations featuring new analyses of Medicare claims data on dementia-related psychosis (DRP) outcomes were presented at Psych Congress 2021, held virtually and in-person October 29-November 1, 2021 in San Antonio, TX. The presentations demonstrate the suboptimal outcomes associated with the off-label use of currently available atypical antipsychotic treatments in managing dementia-related hallucinations and delusions, along with the related cost burdens.

“The suboptimal outcomes and costs associated with off-label use of dopaminergic atypical antipsychotics underscore the challenges health care providers face in appropriately treating patients with dementia-related psychosis, including hallucinations and delusions,” said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia.

Details of the posters presented are as follows:

Poster: Treatment Emergent Adverse Events and Associated Adverse Event-Specific Per-Patient-Per-Year Costs: Analysis of Medicare Beneficiaries Treated with Off-Label Atypical Antipsychotics for Dementia-Related Psychosis: Data from a Medicare claims analysis of 23,267 patients with dementia-related psychosis initiating atypical antipsychotic monotherapy from January 2014 through December 2017 showed that over 70% had one or more adverse events (AEs) within one year, with 64% experiencing dyslipidemia, 50% experiencing peripheral vascular disease (PVD) and 40% experiencing cerebrovascular adverse events (CVAEs) such as stroke and transient ischemic attacks. Median per-patient-per-year (PPPY) costs of hyperlipidemia, PVD, and CVAE were $5,565, $227 and $3,682, respectively.

Poster: Incremental Cost of Treatment Emergent Falls/Fractures, Stroke and Cerebrovascular Adverse Events Among Patients on Atypical Antipsychotics: Analysis of Medicare Patients with Dementia-Related Psychosis: A Medicare claims analysis of 23,267 treated DRP patients showed approximately one in five patients experienced falls/fractures or stroke (23% and 17%, respectively) while nearly two in five patients (38%) experienced other CVAEs including stroke or transient ischemic attacks. The incremental median annual total costs were significantly higher among patients with AEs compared to those without AEs after treatment initiation for falls or fractures ($70,932 vs. $44,221), CVAE ($68,308 vs. $40,061) and stroke ($74,234 vs. $45,999). These results suggest that patients experiencing these AEs had over 60% higher total annual costs compared with those who did not experience the AEs (p<0.05).

Poster: Incremental Cost of Suboptimal Treatment Outcomes Among Patients with Dementia-Related Psychosis: Analysis of Medicare Beneficiaries: An analysis of Medicare claims of 35,100 atypical antipsychotic new start patients with DRP found that nearly two out of three patients experienced at least one suboptimal treatment outcomes (e.g., treatment augmentation, discontinuation or psychosis-specific hospitalizations). Median annual total costs were nearly two times higher ($29,898) among patients with suboptimal outcomes compared with patients who did not experience suboptimal outcomes ($14,158; p<0.05). Total costs also doubled or quadrupled with the occurrence of two or more or four or more suboptimal outcome-events, respectively.

About Dementia-Related Psychosis

Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.¹ In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, which may include hallucinations, delusions, and changes in behavior.

It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions.^2,3 These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Dementia-related psychosis occurs in many types of dementia, including Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality.⁴

About Acadia Pharmaceuticals

Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2020 as well as Acadia’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

References

¹Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

²Plassman BL, et al. Prevalence of dementia in the United States: The Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

³2017 Alzheimer’s Disease Facts and Figures and Acadia market research.

⁴Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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