Otsuka Pharmaceutical Development & Commercialization and Lundbeck Pharmaceuticals said that Rexulti (brexpiprazole) demonstrated clinically meaningful response in Phase 3 trials of patients with dementia due to Alzheimer’s disease (AD).
Rexulti was discovered by Otsuka and is being co-developed by the Japanese firm and Lundbeck Pharmaceuticals.
In May 2023, the US Food and Drug Administration (FDA) approved the drug for agitation associated with dementia due to AD.
New post hoc pooled analyses were from an extension of the Phase 3 study. It evaluated the safety and efficacy of Rexulti for managing agitation in patients with dementia due to AD.
The findings confirmed the effectiveness of the prescription medicine in treating agitation in these patients.
The analysis focused on the clinically meaningful response (CMR) over 12 and 24 weeks, defined as a 20-point reduction from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score.
In the initial 12-week Phase 3 trial, about 62% of patients receiving Rexulti achieved CMR, compared to around 45% of those on placebo.
In the subsequent 12-week extension trial, around 82% of patients who continued Rexulti reached CMR, while roughly 73% of those who switched from placebo to brexpiprazole also achieved CMR.
The second analysis concentrated on 610 patients from two Phase 3 trials who exhibited the highest levels of agitation at baseline.
Patients on brexpiprazole demonstrated a reduction in the frequency of the most common agitation behaviours. The reduction was a numerically greater decrease in the least squares mean CMAI score for 24 out of the 29 behaviours compared to placebo from baseline to Week 12.
Otsuka executive vice president and chief medical officer John Kraus said: “This is the first time Rexulti was associated with a sustained clinically meaningful response over 24 weeks, providing clinicians with longer term data to inform clinical practice.”
Brexpiprazole received US approval in 2015 for adults with major depressive disorder (MDD) and the treatment of schizophrenia.
In Canada, it was approved for schizophrenia in 2017 and for adjunctive treatment of MDD in 2019.
Lundbeck research and development executive vice president Johan Luthman said: “Collectively, the analyses presented add to a substantial body of clinical evidence showing the potential of Rexulti to address the many ways agitation presents itself, which can impact patients’ and their caregivers’ lives.”
