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  5. Drug Trials Snapshots: ZAVZPRET
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Drug Trials Snapshots: ZAVZPRET

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 ZAVZPRET Package Insert for all of 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).

ZAVZPRET (zavegepant)
zav-spret
Pfizer Inc.
Original Approval date: March 9, 2023

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ZAVZPRET is a drug used for the acute treatment of migraine with or without aura in adults.

How is this drug used?

ZAVZPRET is a nasal spray used as needed.

Who participated in the clinical trials?

The FDA approved ZAVZPRET based on data from two clinical trials (Trial 1, NCT04571060 and Trial 2, NCT03872453) of 2,870 patients with migraine headaches with or without aura. Trial 1 included 90 sites and Trial 2 included 82 sites in the United States.

How were the trials designed?

Two double-blind, placebo-controlled, pivotal efficacy trials were conducted which enrolled patients with migraine with or without aura. The design of both trials were similar, although Trial 1 included one dose (ZAVZPRET 10 mg) as compared to placebo, while Trial 2 included three doses (ZAVZPRET 10 mg, zavegepant 5 mg, and zavegepant 20 mg) compared to placebo. Pain freedom and most bothersome symptom (MBS) freedom were assessed at two hours postdose as the primary outcome measures.

The efficacy of ZAVZPRET was based on combined evidence from Trial 1 and Trial 2 comparing ZAVZPRET 10 mg (N=1,014) to placebo (N=1,047).

Patients who completed Trial 1 and Trial 2 could enroll in one additional long term safety study for up to 12 months.

DEMOGRAPHICS SNAPSHOT

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

Figure 1. Baseline Demographics by Sex, Efficacy Population

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 338 (16%) male patients and 1,722 (84%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the side effects of ZAVZPRET.

Figure 2. Baseline Demographics by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 347 (17%) male patients and 1,732 (83%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many patients by sex were in the combined trials used to evaluate the efficacy of ZAVZPRET.

Figure 3. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, and other or multiple race patients were in the clinical trial. In total, 1,675 (81.3%) White patients, 298 (14.5%) Black or African American patients, 61 (3.0%) Asian patients, 4 (0.2%) Native Hawaiian or Pacific Islander patients, 3 (0.1%) American Indian or Alaska Native, and 20 (1.0%) other or multiple race patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by sex were in the combined trials used to evaluate the side effects of ZAVZPRET.

Figure 4. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, and other or multiple race patients were in the clinical trial. In total, 1,686 (81.1%) White patients, 303 (14.6%) Black or African American patients, 63 (3.0%) Asian patients, 4 (0.2%) Native Hawaiian or Pacific Islander patients, 3 (0.1%) American Indian or Alaska Native, and 20 (1.0%) other or multiple race patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 5 summarizes how many patients by race were in the combined trials used to evaluate the efficacy of ZAVZPRET.

Figure 5. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 1,007 (49%) patients younger than 40 years of age, 968 (47%) patients between 40 and 65 years of age, and 86 (4%) patients 65 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 6 summarizes how many patients by race were in the combined trials used to evaluate the side effects of ZAVZPRET.

Figure 6. Baseline Demographics by Age

: Pie chart summarizing how many patients by age were in the clinical trial. In total, 1,019 (49%) patients younger than 40 years of age, 973 (47%) patients between 40 and 65 years of age, and 87 (4%) patients 65 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 7 summarizes how many patients by race were in the combined trials used to evaluate the efficacy of ZAVZPRET.

Figure 7. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic and not Hispanic patients were in the clinical trial. In total, 407 (20%) Hispanic or Latino patients and 1,654 (80%) not Hispanic or Latino patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 8 summarizes how many patients by race were in the combined trials used to evaluate the side effects of ZAVZPRET.

Figure 8. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic and not Hispanic patients were in the clinical trial. In total, 410 (20%) Hispanic or Latino patients and 1,669 (80%) not Hispanic or Latino patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

A higher percentage of patients who received ZAVZPRET were pain free two hours after treatment, in comparison to patients who received placebo. Also, a higher percentage of patients who received ZAVZPRET were free of their most bothersome migraine associated symptoms (such as light sensitivity, sound sensitivity, or nausea) two hours after treatment, in comparison to patients who received placebo.

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

  • Sex: The observed effect of ZAVZPRET was larger for females than males. Because of limited data, this difference may be due to chance.
  • Race: ZAVZPRET worked similarly in White and Black or African American patients.
  • Age: ZAVZPRET worked similarly in patients younger and older than 40 years of age.

What are the possible side effects?

ZAVZPRET may cause hypersensitivity reactions. The most common side effects were taste disorders, nausea, nasal discomfort, and vomiting.

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

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The occurrence of side effects was similar in White and Black or African American patients.
  • Age: The occurrence of side effects was similar in patients younger and older than 40 years of age.

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 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.

DRUG PACKAGE INSERT

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