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

FILE – In this Aug. 14, 2018 file photo, a doctor looks at a PET brain scan at the Banner Alzheimers Institute in Phoenix. Two experimental drugs failed to prevent or slow mental decline in a study of people who are virtually destined to develop Alzheimer’s disease at a relatively young age because of rare gene flaws. The results announced Monday, Feb. 10, 2020, are another disappointment for the approach that scientists have focused on for many years — trying to remove a harmful protein that builds up in the brains of people with the disease.

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.

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

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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, according to the Alzheimer’s Society of Canada (ASC).

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.