Drug to treat agitation in Alzheimer’s patients approved in Canada

Health Canada has green lit a drug previously approved for schizophrenia and depression to treat symptoms of agitation in Alzheimer’s patients.

Rexulti (brexpiprazole) oral tablets manufactured by Otsuka Pharmaceutical Canada Inc. and Lundbeck Canada Inc. were issued a Notice of Compliance by the regulator, according to a company release Wednesday.

This approval was given after three 12-week randomized, double-blind, placebo-controlled studies, the release said.

Approximately half of all patients with Alzheimer’s dementia suffer from agitation, with behaviours such as pacing, gesturing, profanity, shouting, shoving, and hitting, Otsuka Canada said in its release.

Rexulti has been given the green light for managing agitation that is associated with dementia due to Alzheimer’s disease in patients with aggressive behaviour that is unresponsive to non-pharmacological approaches.

The drug was approved for this condition in the United States in May 2023.

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Dr. Sharon Cohen, who is a behavioural neurologist and the medical director of Toronto Memory Program, said there is a “huge unmet need” of vulnerable Alzheimer’s patients who suffer with agitation.

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People with mild dementia due to Alzheimer’s disease can have agitation, but this occurs more so in the moderate and severe stages of disease, according to Cohen, who has been treating people with Alzheimer’s for over 30 years

“Having in our toolkit now a medicine specifically approved for this group of individuals and this specific behaviour of agitation is very important,” Cohen said in an interview with Global News Thursday.

“And it paves the way for further drugs to target psychiatric symptoms in Alzheimer’s disease,” she added.

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Michael Laranjo, president and general manager of Otsuka Canada, hailed Health Canada’s decision as a “major milestone” for patients, caregivers, and families.

Rexulti was already approved in Canada for the treatment of schizophrenia in adults back in 2017 and later as an additional therapy to antidepressants in adults with major depressive disorder (MDD) in 2019.

It is a prescription drug that can be taken once daily with or without food.

The most common side effects include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances, according to the U.S. Food and Drug Administration. (FDA).

More than 600,000 people in Canada are living with dementia, the Alzheimer’s Society of Canada (ASC) estimates.

By 2030, nearly one million people in Canada are forecast to have the cognitive disease.

A study published this week by the Alzheimer’s Society of Canada said there is a growing amount of “young-onset dementia” in the country.

— with files from Global News’ Katie Dangerfield and Katherine Ward.