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Drug Trial Snapshot: Xepi
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 XEPI Prescribing Information for complete information.
XEPI (ozenoxacin)
(ze pee)
Medimetriks Pharmaceuticals
Approval date: December 11, 2017
(ze pee)
Medimetriks Pharmaceuticals
Approval date: December 11, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
XEPI is a drug for treatment of impetigo due to certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients 2 months of age and older.
Impetigo is a contagious bacterial skin infection that occurs primarily in children.
How is this drug used?
XEPI is a cream. It is applied two times a day for 5 days in a thin layer to the areas of skin where impetigo is present.
What are the benefits of this drug?
More patients who were treated with XEPI improved the signs and symptoms of impetigo and had no need for additional antimicrobial therapy in comparison to those who were treated with placebo cream.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: XEPI worked similarly in male and female patients.
- Race: XEPI worked similarly in Black or African American and in White patients. The number of patients in other races was limited; therefore, differences in response among all races could not be determined.
- Age: XEPI worked better in patients younger than 12 years of age than in older ones.
What are the possible side effects?
Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPI reported dermatitis during the trials.
Were there any differences in side effects among sex, race and age?
The total number of patients who had side effects was low and differences by age, sex, and race could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved XEPI based on evidence from two clinical trials (NCT 01397461 and NCT 02090764) of 723 patients with impetigo. The trials were conducted in the USA, Europe, South Africa and Puerto Rico.
The figure below summarizes how many males and females were in the clinical trials.
Figure 1. Baseline Demographics by Sex
FDA Statistical review
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
FDA Statistical review
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 382 | 53 |
| Black or African American | 245 | 34 |
| Asian | 32 | 4 |
| American Indian or Alaska Native | 2 | less than 1 |
| Mixed | 62 | 9 |
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age
FDA Statistical review
How were the trials designed?
The benefit and side effects of XEPI were evaluated in two clinical trials of patients with impetigo. In both trials patients received treatment with either XEPI or placebo cream twice daily for 5 days. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.
At the end of therapy, patients were evaluated for improvement of clinical signs and symptoms of impetigo and need for additional antibacterial treatment.
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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