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Drug Trials Snapshots: REXULTI

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the REXULTI Prescribing Information for complete information.

REXULTI (brexpiprazole)
(REX-ul-TE)
Otsuka America Pharmaceuticals, Inc.
Approval date: July 10, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

REXULTI is a drug for the treatment of major depressive disorder (MDD). In a patient who is already taking a medication for depression that is not adequately treating their symptoms, REXULTI can be added on to improve symptoms.

MDD, commonly referred to as depression, is a brain disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat and enjoy once-pleasurable activities.

How is this drug used?

REXULTI is a tablet that is taken once a day.

What are the benefits of this drug?

REXULTI improved symptoms of depression.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: REXULTI worked similarly in men and women.
  • Race: REXULTI worked similarly in all races studied.
  • Age: REXULTI worked similarly in all age groups studied.

What are the possible side effects?

The most common side effects were weight gain and an inner sense of restlessness, which patients commonly describe as feeling the need to move.

REXULTI can raise the risk of death in elderly who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

REXULTI may increase suicidal thoughts or actions in teenagers, or young adults within the first few months of treatment.

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race, and age.

  • Sex: The risk of overall side effects appeared to be similar in men and women.
  • Race: The risk of overall side effects appeared to be similar in all races studied.
  • Age: The risk of overall side effects appeared to be similar in all age groups studied.

WHO WAS IN THE STUDIES?

Who participated in the clinical trials?

The FDA approved REXULTI based on evidence from two clinical trials of 1054 patients with MDD. The trials were conducted in the United States, Canada, and Europe.

The figure below summarizes how many men and women participated in the clinical trials. The population represents the Safety population (1054 patients), which includes any patient who received at least one dose of trial drug.

Figure 1. Baseline Demographics by Sex

Figure 1. Baseline Demographics by Sex REXULTI

Source: Company Clinical Trial Data

The figure and table below summarize how many patients by race participated in the clinical trials. The population represents the Safety population (1054 patients), which includes any patient who received at least one dose of trial drug.

Figure 2. Baseline Demographics by Race

Bar chart summarizing the percentage of patients by race enrolled in the REXULTI clinical trial. In total, 900 White (85%), 126 Black (12%), 9 Asian (1%), 6 American Indian or Alaska Native (1%), 11 identified as Other (1%), and 2 could not be identified (less than 1%).

*=defined as any race not included in other categories
Source: Company Clinical Trial Data

Table 1. Baseline Demographics by Race

Race Number of Patients Percentage of Patients
White 900 85%
African American 126 12%
Asian 9 1%
American Indian or Alaska Native 6 1%
Other* 11 1%
Unknown 2 less than 1%

*= defined as any race not included in other categories
Source: Company Clinical Trial Data

The figure below summarizes how many patients by age participated in the clinical trials. The population represents the Safety population (1054 patients), which includes any patient who received at least one dose of trial drug.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the REXULTI clinical trial.  In total, 1047 were between 18 and 64 years (99%) and 7 were 65 years and older (30%).

Source: Company Clinical Trial Data

How were the trials designed?

There were two trials that evaluated the benefit and side effects of REXULTI. In each trial, patients were randomly assigned to receive either REXULTI or placebo once daily for 6 weeks in addition to the antidepressant medication that they were already taking. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.

The trials measured overall improvement in the symptoms of depression.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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