Rexulti approved in Canada for agitation in Alzheimer’s dementia

Therapy was recently approved for the same indication in the US

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by Andrea Lobo |

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Health Canada has approved Rexulti (brexpiprazole) for agitation associated with Alzheimer’s disease-related dementia in patients with aggressive behavior.

The treatment, co-developed by Otsuka Pharmaceuticals and Lundbeck, was recently approved by the U.S. Food and Drug Administration (FDA) for the same indication.

“Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” Michael Laranjo, president and general manager of Otsuka Canada, said in a company press release.

Rexulti’s recommended starting dose is 0.5 mg taken once daily for one week, followed by 1 mg once daily for another week, and 2 mg once daily thereafter. The dosing may be increased up to a maximum daily dose of 3 mg after at least two weeks, based on a patient’s clinical response and tolerability.

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FDA approves Rexulti for agitation tied to Alzheimer’s dementia

Treatment addresses common Alzheimer’s symptom

“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, Lundbeck Canada’s vice president and general manager.

Alzheimer’s disease is the most common cause of dementia, a group of cognitive symptoms including memory loss, confusion, and impaired reasoning skills. Agitation, which is characterized by abnormal or inappropriate displays of emotion, affects about half of all people with dementia due to Alzheimer’s disease.

Rexulti is an oral antipsychotic medication thought to work by modulating the activity of certain signaling molecules in the brain. It was previously approved in Canada for schizophrenia in adults, as well as for major depressive disorder in adults when given along with antidepressant medications.

The treatment’s new approval was supported by data from three Phase 3 trials: two fixed-dose studies — Study 331-12-283 (NCT01862640) and Study 331-14-213 (NCT03548584) — and one flexible-dose study, Study 331-12-284 (NCT01922258). Collectively, the trials enrolled a total of 1,048 people with agitation associated with Alzheimer’s dementia.

All the trials investigated Rexulti treatment compared with a placebo once daily for 12 weeks, but differed in their dosing regimens. The two first trials treated patients with fixed doses of 1, 2, or 3 mg a day, while the other used a flexible range of doses ranging from 0.5 mg to 2 mg per day.

The trials’ main goal was to assess Rexulti’s impact on the frequency of agitation symptoms, using the standard assessment tool Cohen-Mansfield Agitation Inventory (CMAI). Researchers also evaluated agitation using the Clinical Global Impression-Severity of Illness score.

In both fixed-dose trials, results showed CMAI agitation scores decreased significantly more for patients given Rexulti — by 31% — than for those on the placebo.

Safety data from the studies were generally consistent with the known safety profile of Rexulti in other populations. Common side effects observed included dizziness, headache, and urinary tract infection.

“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,” said Zahinoor Ismail, MD, a professor at the University of Calgary who has studied brexpiprazole. “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.”