Drugs

Drug Trials Snapshots: ARISTADA

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 ARISTADA Prescribing Information for complete information.

ARISTADA (aripiprazole laurixil)
(air-is-TAH-dah)
Alkermes Inc.
Approval date: October 5, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ARISTADA is a drug used for the treatment of schizophrenia.

Schizophrenia is a brain disorder characterized by hearing voices, believing other people are reading one’s mind or controlling one’s thoughts, and being suspicious or withdrawn.

How is this drug used?

ARISTADA is an injection given into the muscle of the arm or buttock by a healthcare provider once a month to once every 6 weeks.

What are the benefits of this drug?

ARISTADA improved symptoms of schizophrenia.

What are the benefits of this drug?

The table below summarizes the primary efficacy endpoints. This was based on the mean change in the Positive and Negative Syndrome Scale (PANSS) total score after 12 weeks. The population represents Full analysis set (FAS) and consists of all randomized patients who received at least one injection dose of study drug and had at least one post-randomization efficacy evaluation for PANSS total score.

Table 2. Summary of Efficacy Results (FAS population)

Trial NumberTreatment GroupPrimary Efficacy Measure: PANSS Total Score
 Mean Baseline Score (SD)LS Mean Change from Baseline (SE)Placebo-subtracted Differencea
(95% CI)
Trial 1ARISTADA 441 mgb92.6 (10.2)-20.9 (1.4)-10.9 (-14.5, -7.3)
 ARISTADA 882 mgb92.0 (10.8)-21.8 (1.4)-11.9 (-15.4, -8.3)
 Placebo93.9 (11.3)-9.8 (1.4)--

SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval, not adjusted for multiple comparisons.
a Difference (drug minus placebo) in least-squares mean change from baseline.
b Doses that are demonstrated to be effective.
Source: Prescribing Information, Section 14, Table 13

 

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

Subgroup analyses were conducted for sex and race.

  • Sex: ARISTADA worked similarly in men and women.
  • Race: ARISTADA worked similarly in all races studied.
  • Age:: Most patients in the trial were 18 to 66 years old. Differences in how well ARISTADA worked in patients below and above 65 years of age could not be determined.

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

The figures below summarize the responses to ARISTADA by sex and race subgroups for the FAS population which includes all randomized patients who received at least one injection dose of study drug and had at least one post-randomization efficacy evaluation for PANSS total score.

Figure 3. Subgroup Analysis of Primary Endpoint by Sex

Figure summarizes the responses to ARISTADA by sex and race subgroups for the FAS population which includes all randomized patients who received at least one injection dose of study drug and had at least one post-randomization efficacy evaluation for PANSS total score.

Source: FDA Statistical Review

Figure 4. Subgroup Analysis of Primary Endpoint by Race

Figure summarizes the responses to ARISTADA by sex and race subgroups for the FAS population which includes all randomized patients who received at least one injection dose of study drug and had at least one post-randomization efficacy evaluation for PANSS total score.

Source: FDA Statistical Review

What are the possible side effects?

The most common side effect of ARISTADA was akathisia, which is the urge to move constantly.

What are the possible side effects?

The table below summarizes adverse reactions in the Safety population defined as all patients who received at least one injection dose of study drug.

Table 3. Adverse Reactions that Occurred in 2% or more of ARISTADA-Treated Patients and at Greater Incidence than in the Placebo-Treated Patients

Adverse ReactionPlacebo
N=207
(%)
ARISTADA
441 mg
N=207
(%)
882 mg
N=208
(%)
General disorders and administration site conditions
Injection site pain234
Investigations
Increased weight122
Increased blood creatine phosphokinase021
Nervous system disorders
Akathisia41111
Headache335
Psychiatric disorders
Insomnia234
Restlessness131

Source: ARISTADA Prescribing Information, Section 6, Table 10

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

Subgroup analyses were conducted for sex and race.

  • Sex: Akathisia (the urge to move constantly) was seen more frequently in men compared to women.
  • Race: Akathisia (the urge to move constantly) was seen more frequently in blacks/African Americans compared to whites.
  • Age: Most patients in the trial were 18 to 66 years old. Differences in side effects of ARISTADA in patients below and above 65 years of age could not be determined.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes akathisia in the Safety population defined as all patients who received at least at least one injection dose of study drug.

Table 4. Subgroup Analysis of Akathisia Adverse Event

SubgroupARISTADA
441mg
(N=207)
n(%)
ARISTADA
882mg
(N=208)
n(%)
Placebo
(N=207)
n(%)
x (%)**Total, nx (%)**Total, nx (%)**Total, n
Akathisia24 (11.6)20724 (11.5)2089 (4.4)207
Sex
Male20 (14.2)14121 (14.7)1434 (2.9)138
Female4 (6.1)663 (4.6)655 (7.3)69
Race
White9 (9.1)998 (8.2)986 (6.4)94
Black or African American13 (15.7)8314 (17.3)813 (3.6)84
Asian1 (4.2)242 (7.1)280 (0)28
American Indian or Alaska Native0 (0)00 (0)10 (0)1
Native Hawaiian or Other Pacific Islander1 (100)10 (0)00 (0)0

X (%)**=number and percentage of patients in that subgroup that had akathisia
Source: Company Trial data

WHO WAS IN THE STUDIES?

Who participated in the clinical trials?

The FDA approved ARISTADA based partly on previous evidence from trials using the oral formulation of aripiprazole. In addition, the benefit or ARISTADA was assessed with evidence from one clinical trial that enrolled 623 patients with schizophrenia. The trial was conducted in the United States, Europe, and Asia.

The figure below summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the clinical trials used to evaluate efficacy of the drug ARISTADA.  In total, 423 men (68%) and 200 women (32%) participated in the clinical trial used to evaluate efficacy of the drug ARISTADA.

Source: FDA Review Division

The figure and table below summarize the percentage of patients by race enrolled in the clinical trial.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the ARISTADA clinical trial. In total, 291 Whites (47%), 248 Blacks (40%), 81 Asians (13%), 2 American Indian or Alaska Natives (<1%), and 1 Native Hawaiian or Other Pacific Islander (<1%) participated in the clinical trial.)

<1%=less than 1%
Source: FDA Review Division

Table 1. Demographics of Trial by Race

RaceNumber of patientsPercentage of patients
White29147%
Black or African American24840%
Asian8113%
American Indian or Alaska Native2<1%
Native Hawaiian or Other Pacific Islander1<1%

<1%=less than 1%
Source: FDA Review Division

The figure below summarizes how many patients by age were enrolled in the clinical trial. All subjects were in the 18 to 66 year old range.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the ARISTADA clinical trial.  In total, all 623 participants were between 18 and 66 years old (100%).

Source: FDA Review Division

Who participated in the trials?

The table below summarizes baseline demographics for the randomized population.

Table 5. Baseline Demographics for the Trial

SubgroupPlacebo
(N=208)
n (%)
ARISTADA 441 mg
(N=207)
n (%)
ARISTADA 882 mg
(N=208)
n (%)
Total (N=623)
n (%)
Sex
Male139 (67)141 (68)143 (67)423 (68)
Female69 (33)66 (32)65 (31)200 (32)
Age (years)
Mean (SD)40 (12)40 (10)40 (11)40 (11)
Median39394039
Min-Max18-6618-6120-6518-66
Race
White94 (45)99 (48)98 (47)291 (47)
Black or African American84 (40)83 (40)81 (39)248 (40)
Asian29 (14)24 (12)28 (14)81 (13)
American Indian or Alaska Native1 (<1)01 (<1)2 (<1)
Native Hawaiian or Other Pacific Islander01 (<1)01 (<1)
Region
United States102 (49)103(50)102 (49)307 (49)
Europe80 (39)81 (39)78 (38)239 (39)
Asia26 (13)23 (11)28 (14)77 (12)

Source: Review Division

How were the trials designed?

There was one trial that evaluated the benefit and side effects of ARISTADA. In the trial, patients were randomly assigned to receive either ARISTADA or placebo. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.

The trial lasted 12 weeks, and measured overall improvement in the symptoms of schizophrenia at the end of the trial.

How were the trials designed?

ARISTADA was studied in a 12-week, randomized, double-blind, placebo controlled, fixed-dose trial in adult patients with acutely-relapsed schizophrenia who met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, (DSM IV TR) criteria.

ARISTADA or placebo injections were administered on Days 1, 29, and 57. Patients also received an oral study drug (aripiprazole or placebo) daily on Days 1 through 21.

The primary endpoint was the change from baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS) total score.

The PANSS is a 30-item scale that measures positive symptoms of schizophrenia (7 items), negative symptoms of schizophrenia (7 items), and general psychopathology (16 items), each rated on a scale of 1 (absent) to 7 (extreme); the total PANSS scores range from 30 to 210.

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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Page Last Updated: 05/09/2017
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