View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
June 27, 2022

Otsuka, Lundbeck report positive data from Phase III Alzheimer’s trial

The CMAI total score in brexpiprazole group was statistically higher than for those receiving placebo.

Otsuka Pharmaceutical and H. Lundbeck have reported positive data from the Phase III clinical trial of brexpiprazole to treat agitation in Alzheimer’s dementia patients.

The multicentre, randomised, double-blind, placebo-controlled, fixed-dose trial evaluated the efficacy, safety, and tolerability of two fixed doses of brexpiprazole that include 2mg per day or 3mg a day.

It included 345 participants aged 55 to 90 years (inclusive), who are with a diagnosis of probable Alzheimer’s disease.

It involved a continuous, 12-week double-blind treatment period with follow-up for 30 days.

The findings from the study showed that the patients who have received treatment with brexpiprazole had a statistically significant reduction in agitation compared to placebo.

The Cohen-Mansfield Agitation Inventory (CMAI) total score in participants receiving brexpiprazole was statistically higher compared to those in the placebo group.

A statistically superior improvement of Severity of Illness (CGI-S) score, as related to symptoms of agitation was also observed.

Headache was the only treatment-emergent adverse event (TEAE) observed in patients treated with brexpiprazole.

Otsuka Pharmaceutical said in a statement: “Brexpiprazole was generally well tolerated, and no new safety signals were observed.

“The following TEAEs occurred at an incidence of at least 2% in the brexpiprazole treatment group and greater than that of placebo: somnolence, nasopharyngitis, dizziness, diarrhea, urinary tract infection, and asthenia.”

The companies will further analyse the data set for determining the complete potential of brexpiprazole to treat agitation in Alzheimer’s dementia patients.

Later this year, they are also planning for a regulatory filing to the FDA using the results from the Phase III clinical trial.

The regulator granted Fast Track designation to speed up the review of brexpiprazole, in February 2016.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena