Drugs

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


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.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes efficacy results for the clinical trials based on the primary efficacy endpoint defined as the proportion of patients at Day 6-7 who achieved clinical success defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms using Skin Infection Rating Scale (SIRS) score.

Table 2. Clinical Response at End of Therapy in Trial 1 and Trial 2 in All Randomized Patients

 Trial 1Trial 2
 XEPIPlaceboXEPIPlacebo
(N = 155)
n (%)
(N = 156)
n (%)
(N = 206)
n (%)
(N = 206)
n (%)
Clinical success54 (34.8)30 (19.2)112 (54.4)78 (37.9)
Clinical failure98 (63.2)120 (76.9)91 (44.2)121 (58.7)
Unable to determine3 (1.9)6 (3.8)3 (1.5)7 (3.4)

XEPI Prescribing Information

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.

 

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

Tables below summarize efficacy results by subgroup for each trial based on the ITT population.

Table 3. Success Rates by Sex, Race, Age and Geographic Region, for Trial 1 (ITT)

 XEPI (N=155)Placebo (N=156)Difference (95% CI)
Sex
Male38/99 (38.4%)19/96 (19.8%)18.6% (5.9%, 30.8%)
Female16/56 (28.6%)11/60 (18.3%)10.3% (-5.3%, 25.7%)
Race
White13/58 (22.4%)10/62 (16.1%)6.3% (-8.0%, 20.8%)
Black or African American37/77 (48.1%)17/77 (22.1%)26.0% (11.0%, 39.9%)
Mixed/Other4/20 (20.0%)3/17 (17.6%)2.4% (-25.2%, 28.2%)
Age
2 yrs. - < 12 yrs.34/94 (36.2%)16/94 (17.0%)19.2% (6.6%, 31.3%)
≥ 12 yrs.20/61 (32.8%)14/62 (22.6%)10.2% (-5.7%, 25.8%)
12 - < 18 yrs.6/19 (31.6%)1/18 (5.6 %)26.0% (0.5%, 50.1%)
< 18 yrs.40/113 (35.4%)17/112 (15.2%)20.2% (9.0%, 31.2%)
≥ 18 yrs.14/42 (33.3%)13/44 (29.5%)3.8% (-15.8%, 23.3%)
Geographic Region
US/Europe8/49 (16.3%)10/58 (17.2%)-0.9% (-15.3%, 14.2%)
South Africa46/106 (43.4%)20/98 (20.4%)23.0% (10.3%, 35.0%)

 

Table 4. Success Rates by Sex, Race, Age and Geographic Region, for Trial 2 (ITT)

 XEPI (N=206)Placebo (N=206)Difference (95% CI)
Sex
Male60/112 (53.6%)33/98 (33.7%)19.9% (6.4%, 32.6%)
Female52/94 (55.3 %)45/108 (41.8%)13.7% (-0.2%, 27.0%)
Race
White58/112 (51.8%)39/140 (27.9%)23.9% (11.9%, 35.5%)
Black or African American43/53 (81.1%)27/38 (71.1%)10.1% (-7.4%, 28.5%)
Mixed/Other11/31 (35.5%)12/25 (48.0%)-12.5% (-37.1%, 13.3%)
Age
2 mo. - < 12 yrs.73/114 (64.0%)44/113 (38.9%)25.1% (12.2%, 37.2%)
2 mo. - < 2 yrs.7/12 (58.3%)6/16 (37.5%)20.8% (-16.5%, 53.1%)
2 - < 12 yrs.66/102 (64.7%)38/97 (39.2%)25.3% (11.7%, 38.4%)
≥ 12 yrs.39/92 (42.4%)34/93 (36.6%)5.8% (-8.3%, 19.7%)
12 - < 18 yrs.8/23 (34.8%)8/23 (34.8%)0.0% (-27.1%, 27.1%)
≥ 18 yrs.31/69 (44.9%)26/70 (37.1%)7.8% (-8.6%, 23.8%)
< 18 yrs.81/147 (59.1%)52/136 (38.2%)16.9% (5.2%, 28.0%)
Geographic Region
US25/65 (38.5)16/75 (21.3)17.1% (2.0%, 32.0%)
South Africa37/43 (86.1)27/34 (79.4)8.6% (-10.5%, 25.0%)
Europe40/75 (53.3)26/74 (35.1)18.2% (2.2%, 33.3%)

Adapted from FDA Statistical Review

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.

What are the possible side effects (results of trials used to assess safety)?

Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with XEPI.

XEPI Prescribing Information

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.

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

Differences in side effects in the clinical trials among sex, race, and age groups were not assessed because of the limited number of overall side effects in the trials.

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

Pie chart summarizing how many male and female patients were in the clinical trials. In total, 405 males  (56%) and 318 females (44%) participated in the clinical trials.

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

Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 382 White (53%), 245 Black or African American (34%), 62 mixed race  (8%), and 34 all  other (5%) participate FDA Statistical review

 

Table 1. Baseline Demographics by Race

RaceNumber of PatientsPercentage
White38253
Black or African American24534
Asian324
American Indian or Alaska Native2less than 1
Mixed629

Figure 3 summarizes the percentage of patients by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were in the clinical trials. In total, 28 patients were less than 2 years old (4%) 387 were between 2 and 12 years old (54%), 83 were between 12 and 18 years old (11%) and 225 patients were 18 and older (31%).

FDA Statistical review

The table below summarizes patients by subgroup for the ITT population in the clinical trials.

Table 5. Baseline Demographics of Patients in the Clinical Trials (ITT population)

 Trial 1Trial 2
XEPI (N=155)Placebo (N=156)XEPI (N=206)Placebo (N=206)
Age (years)
Median (median)16.1 (9.0)17.3 (10.0)18.8 (10.8)18.6 (10.4)
Age Groups    
2 months-2 years0012 (5.8)16 (7.7)
2-12 years94 (60.6)94 (60.3)102 (49.5)97 (47.1)
12-18 years19 (12.2)18 (11.5)23 (11.2)23 (11.2)
18-65 years36 (23.1)40 (25.6)66 (32.0)63 (30.6)
≥65 years6 (3.8)4 (2.6)3 (1.5)7 (3.4)
Sex
Male99 (63.9%)96 (61.5%)112 (54.4)98 (47.8)
Female56 (35.9%)60 (38.5%)94 (45.6)108 (52.4)
Race
White58 (37.2%)62 (39.7%)122 (59.2)140 (68.0)
Black or African American77 (49.7%)77 (49.4%)53 (25.7)38 (18.5)
Mixed19 (12.2%)15 (9.6%)15 (7.3)13 (6.3)
Asian1 (0.6%)016 (7.8)15 (7.3)
American Indian or Alaska Native02 (1.3%)00

Adapted from 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.

How were the trials designed?

The safety and efficacy of XEPI were established in 2 randomized, double-blind, placebo-controlled trials of 1 week duration. All patients with predetermined impetigo surface area were randomized 1:1 to receive XEPI or placebo cream applied twice daily for 5 days.

The primary efficacy outcome measure was the proportion of patients at the end of the treatment who achieved clinical success defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms using Skin Infection Rating Scale (SIRS) score.

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: 01/04/2018
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