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  5. Drug Trials Snapshots: ZURZUVAE
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Drug Trials Snapshots: ZURZUVAE

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic 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 healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ZURZUVAE Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

ZURZUVAE (zuranolone)
(ZUR-zoo-vay)
Biogen, Inc.
Approval date: August 4, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ZURZUVAE is a neuroactive steroid drug used for the treatment of postpartum depression in adults.

How is this drug used?

ZURZUVAE is given as capsules taken by mouth once daily in the evening with fat-containing food for 14 days.

Who participated in the clinical trials?

The FDA approved ZURZUVAE based on evidence from two clinical trials of 345 patients with postpartum depression. The trials were conducted at 125 sites in 3 countries in the United States, Spain, and the United Kingdom.

In Trials 1 and 2, the baseline demographics of patients were similar between the ZURZUVAE and placebo groups. In Trial 1, 98% of patients were enrolled in the United States; patients had a mean age of 30 years (range 19 to 44 years); 70% of patients were White, 22% Black or African American, 1% Asian, and 7% other races; and 38% of patients were of Hispanic or Latino ethnicity. In Trial 2, all patients were enrolled in the United States; patients had a mean age of 28 years (range 18 to 44 years); 56% of patients were White, 41% Black or African American, 1% Asian, and 2% other races; and 23% of patients were of Hispanic or Latino ethnicity.

The same trials were used to assess efficacy and safety. The number of patients representing efficacy findings may differ from the number of patients representing safety findings due to different pools of study participants analyzed for efficacy and safety.

How were the trials designed?

ZURZUVAE was evaluated in two clinical trials of 345 patients with postpartum depression.

Both 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 four 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 eight items on a 5-point grading scale (not present to severe). Both trials enrolled patients with severe postpartum depression (HAM-D score of ≥26), and use of another oral antidepressant at a stable dose was allowed. Patients in Trial 1 were randomized to receive ZURZUVAE 50 mg or placebo once daily for 14 days. Patients in Trial 2 were randomized to receive another zuranolone capsule formulation (approximately equal to ZURZUVAE 40 mg) or placebo once daily for 14 days. 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 ZURZUVAE was assessed in both trials by determining the improvement in depressive symptoms (the difference in HAM-D scores before and after treatment).


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many male and female patients were enrolled in the clinical trials used to evaluate the efficacy of ZURZUVAE.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 0 (0%) male patients and 345 (100%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race were enrolled in the clinical trials used to evaluate the efficacy of ZURZUVAE.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian or Native Hawaiian or other Pacific Islander, American Indian or Alaska Native, multiple races, not reported, and other patients were in the clinical trial. In total, 221 (63.7%) White patients, 106 (30.5%) Black or African American patients, 5 (1.4%) Asian, Native Hawaiian, or other Pacific Islander patients, 3 (0.9%) American Indian or Alaska Native patients, 6 (1.7%) multiple race patients, 2 (0.6%) patients with race reported, and 4

Source: Adapted from FDA Review

Figure 3 summarizes the percentage of patients by age were enrolled in the clinical trials used to evaluate the efficacy of ZURZUVAE.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 73 (21%) patients younger than 25 years of age and 274 (79%) patients 25 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes the percentage of patients by ethnicity were enrolled in the clinical trials used to evaluate the efficacy of ZURZUVAE.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and not reported patients were in the clinical trial. In total, 109 (31.4%) Hispanic or Latino patients, 237 (68.3%) not Hispanic or Latino patients, and 1 (0.3%) not reported patient participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In two trials, patients with severe postpartum depression who were given ZURZUVAE 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 trials were female.
  • Race: ZURZUVAE worked similarly in White and Black or African American patients. The number of patients in other races was limited; therefore, differences in how well ZURZUVAE worked in other races could not be determined.
  • Age: Fewer patients younger than 25 years old were enrolled in the studies. Differences in how well ZURZUVAE worked in patients younger and older than 25 years of age could not be determined. All patients were younger than 65 years of age.

What are the possible side effects?

ZURZUVAE may cause serious side effects such as decreased ability to drive or do other dangerous activities, decreased awareness and alertness (sleepiness and confusion), increased risk of suicidal thoughts or actions, and risk of harm to the fetus while pregnant. The most common side effects in the trials were sleepiness or drowsiness; dizziness; diarrhea; feeling tired, weak, or having no energy; common cold; and urinary tract infection.

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

  • Sex: All patients in the trials were female.
  • Race: In Trial 1, the occurrence of side effects was better in Black or African American patients. In Trial 2, the occurrence of side effects was better in White patients. Given these differences in Trials 1 and 2 and the limited number of patients in other races, differences in the occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effects was better in patients aged 25 years and older. However, the number of patients in the younger than 25-year-old age subgroup was limited; therefore, differences in the occurrence of side effects among age subgroups should be interpreted with caution.

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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