A new DRUG TRIALS SNAPSHOT is now available.
Drug Trials Snapshots: ZULRESSO
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.
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 ZULRESSO Package Insert for complete information.
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 ZULRESSO Package Insert for complete information.
ZULRESSO (brexanolone)
zul reh’ soe
Sage Therapeutics, Inc.
Approval date:March 19, 2019
zul reh’ soe
Sage Therapeutics, Inc.
Approval date:March 19, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
ZULRESSO is a drug used to treat adult women with postpartum depression (an episode of major depression starting in the third trimester of pregnancy or within 4 weeks after delivery).
How is this drug used?
ZULRESSO is given as an intravenous infusion (injected into a vein) by a healthcare provider. The intravenous infusion takes about 60 hours (2 ½ days) to complete.
The dose depends on the patient’s weight.
What are the benefits of this drug?
In two trials, patients with moderate or severe postpartum depression who were given ZULRESSO, achieved more improvement of depressive symptoms than patients given placebo.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: All patients in the trial were women.
- Race: ZULRESSO worked similarly in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in how well ZULRESSO worked in other races could not be determined.
- Age:ZULRESSO worked similarly in patients less than and older than 27 years of age. All patients were less than 65 years of age.
What are the possible side effects?
ZULRESSO may cause serious side effects such as excess sleepiness and sudden loss of consciousness (unable to respond). Because of this risk ZULRESSO is available only through a restricted program called ZULRESSO REMS.
The most common side effects in the trials were sleepiness, dry mouth, loss of consciousness, and hot flashes.
Were there any differences in side effects among sex, race and age?
- Sex: All patients were women.
- Race:The occurrence of side effects was similar in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among other races could not be determined.
- Age: The occurrence of side effects was similar in patients less than and older than 27 years of age. All patients were less than 65 years of age.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved ZULRESSO based on evidence from three clinical trials (Trial 1/NCT02942004, Trial 3/NCT02614541, Trial 2/ NCT02942017) of 247 women with moderate or severe postpartum depression. The trials were conducted in the United States.
The population that provided data for side effects of ZULRESSO (safety population) is presented below.
Figure 1 summarizes how many women were in the clinical trials used to evaluate safety.
Figure 1. Baseline Demographics by Sex
FDA Review
Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate safety.
Figure 2. Baseline Demographics by Race
*Other includes Asian, American Indian or Alsaka Native, and Native Hawaiian or Other Pacific Islander
FDA Review
Table 1. Demographics of Safety Trials by Race
Race
|
Number of Patients
|
Percentage of Patients
|
|---|---|---|
White
|
151
|
61%
|
Black or African American
|
89
|
36%
|
Asian
|
1
|
Less than 1%
|
American Indian or Alaska Native
|
1
|
Less than 1%
|
Native Hawaiian or Other Pacific Islander
|
1
|
Less than 1%
|
Other
|
4
|
2%
|
FDA Review
Figure 3 summarizes the percentage of patients by age group in the clinical trials used to evaluate safety.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit of ZULRESSO was primarily evaluated in two clinical trials and the side effects in three clinical trials.
All trials enrolled patients 18 to 45 years old with postpartum depression who had an episode of major depression starting in the third trimester of pregnancy or within 4 weeks after delivering a baby. The investigator used the Hamilton Depression Rating Scale (HAM-D) to determine the patient’s level of depression. The HAM-D scores 8 items on a 5-point grading scale (0 = not present to 4 = severe) and 9 items on a 3-point grading scale (0 = not present to 2 = severe).
Trial 1 enrolled patients with severe postpartum depression (a HAM-D score of ≥26) and Trial 2 enrolled patients with moderate postpartum depression (a HAM-D score of 20 to 25). Patients in Trial 1 were randomized to receive a single 60-hour intravenous infusion of one of two doses of ZULRESSO or placebo. Patients in Trial 2 were randomized to receive a single dose of ZULRESSO or placebo through a 60-hour intravenous infusion. In both trials, neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of ZULRESSO was assessed in both trials by determining the improvement in depressive symptoms (the difference in HAM-D scores before and after treatment).
In Trial 3, patients with severe postpartum depression were randomized to receive a single dose of ZULRESSO or placebo through a 60-hour intravenous infusion. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. Assessment of side effects included data from Trial 3.
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.
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.
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