Health Canada Approves Otsuka and Lundbeck's REXULTI® (brexpiprazole) for the Symptomatic Management of Agitation Associated with Alzheimer's Dementia

MONTREAL, QC, Jan. 24, 2024 /CNW/ - Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for REXULTI^® (brexpiprazole) for use in the symptomatic management of agitation associated with Alzheimer's dementia (AAD) in patients with aggressive behaviour, unresponsive to non-pharmacological approaches.

The approval was based on three Phase 3, 12-week, randomized, double-blind, placebo-controlled studies (two fixed-dose and one flexible dose) that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer's disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score. The primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at Week 12 in all studies. 

Dr Zahinoor Ismail, MD, FRCPC said: ''Expanding treatment options for this vulnerable population is a positive advancement. When non-pharmacological treatments are ineffective for reducing agitation in persons with Alzheimer's disease, and intervention is required, we tend to use older medications. The approval of REXULTI for managing agitation symptoms in Alzheimer's disease patients is a valuable addition with a novel approach that can contribute to better care and improved outcomes for this deserving group of individuals and their caregivers.''  

Michael Laranjo, President and General Manager of Otsuka Canada, commented, "Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer's disease. Otsuka Canada will continue its efforts to engage and provide options for those impacted by this devastating condition."

"This approval is a testament to our tireless dedication to patients and their caregivers, and we are proud to offer this additional treatment option to Canadians living with Alzheimer's disease," said Michal Juul Sørensen, Vice President and General Manager, Lundbeck Canada.

About Agitation Associated with Alzheimer's Dementia
Agitation associated with Alzheimer's dementia is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alzheimer's dementia. The condition has a large impact on the quality of life for the patients, family members, and caregivers.^1-3

Agitation associated with dementia covers a large group of behaviours occurring in patients with Alzheimer's disease, such as pacing, gesturing, profanity, shouting, shoving, and hitting.⁴ Symptoms of agitation are also a consistent predictor of nursing home admission in patients with dementia, including those with Alzheimer's disease.^5-7 

About Brexpiprazole
REXULTI^® (brexpiprazole) was discovered by Otsuka and co-developed with Lundbeck. It is comarketed by the two companies.

REXULTI^® (brexpiprazole) was approved by Health Canada in 2017 for the treatment of schizophrenia in adults and later obtained approval as an adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) in 2019.

REXULTI^® is given in a once-daily oral dose that can be taken with or without food.⁸   

REXULTI is not indicated as an as needed ("prn") treatment for symptoms of agitation associated with Alzheimer's dementia.⁸

Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. When considering the use of REXULTI for the treatment of AAD, clinicians are advised to assess the risks and benefits of the use of REXULTI in elderly patients with AAD keeping in mind the increased risk of mortality in this patient population treated with antipsychotics and the risk predictors for stroke or existing cardiovascular comorbidities.⁸  

For more information about REXULTI^®, please visit http://otsukacanada.com or https://www.lundbeck.com/ca. 

About Otsuka
Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing healthcare company that commercializes Otsuka medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardio-renal, and nephrology. OCPI was established in 2010, with headquarters in Saint-Laurent, Quebec. 

OCPI is part of Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy: "Otsuka – people creating new product for better health worldwide." Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. 

Otsuka Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employed approximately 47,000 people worldwide and had consolidated sales of approximately USD 13.1 billion in 2022. 

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka on our global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.com.

About Lundbeck
Since 1995, Lundbeck Canada has been striving to improve the lives of Canadians living with brain diseases. As a subsidiary of H. Lundbeck A/S, a global pharmaceutical company specialized in brain diseases, we benefit from more than 70 years at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Lundbeck's research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any, therapeutic options. 

For additional information, please visit our corporate website www.lundbeck.com/ca.

References: 

1.	Halpern R et al. Using electronic health records to estimate the prevalence of agitation in Alzheimer disease/dementia. Int J Geriatr Psychiatry. 2019;34:420–431.
2.	Gaugler JE et al. Predictors of nursing home admission for persons with dementia. Med Care 2009;47:191–198.
3.	Fillit H et al. Impact of agitation in long-term care residents with dementia in the United States. Int J Geriatr Psychiatry. 2021;36:1959–1969.
4.	Cummings J et al. Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition. Int Psychogeriatr. 2015;27:7–17.
5.	Gaugler JE et al. Predictors of nursing home admission for persons with dementia. Med Care 2009;47:191–198.
6.	Kales HC et al. Rates of clinical depression diagnosis, functional impairment, and nursing home placement in coexisting dementia and depression. Am J Geriatr Psychiatry. 2005;13:441– 449.
7.	Yaffe K et al. Patient and caregiver characteristics and nursing home placement in patients with dementia. JAMA. 2002;287:2090–2097.
8.	REXULTI Product Monograph. Otsuka Pharmaceutical Co., Ltd.

SOURCE Otsuka Canada Pharmaceutical Inc.

Otsuka Canada Pharmaceutical Inc: Milena Bembic, [email protected]; Lundbeck Canada: Stella Antonaras, [email protected]