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Drug Trial Snapshot: XEGLYZE

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 the  XEGLYZE Package Insert for complete information.

XEGLYZE (abametapir)
(zeg’ lyze)
Dr. Reddy’s Laboratories
Approval date: July 24, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

XEGLYZE is a drug used to treat head lice in patients 6 months of age and older.

How is this drug used?

XEGLYZE is a lotion applied once to dry hair.

What are the benefits of this drug?

About 80% of patients treated with XEGLYZE were free of live lice in comparison to about 50% of patients who were treated with placebo.

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

  • Sex: The majority of patients in the trials were females. XEGLYZE appeared to be similarly effective in males and females.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how XEGLYZE worked among races could not be determined.
  • Age: XEGLYZE worked similarly in all tested age groups.

What are the possible side effects?

XEGLYZE contains benzyl alcohol which may cause serious injury if accidentally ingested or used in patients younger than 6 months.

The most common side effects of XEGLYZE are skin redness, rash, skin burning sensation, skin inflammation, vomiting, eye irritation, skin itching, and hair color changes.

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

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effects was similar among tested age groups.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved XEGLYZE based on evidence from two identical clinical trials of 699 patients with head lice. The trials were conducted at 14 sites in the United States.

The population that provided data for the evaluation of side effects (safety population) is presented below. Demographics of the patients who provided data for evaluation of benefits are presented in Table 8, under the MORE INFO section.

Figure 1 summarizes how many males and females were in the clinical trials used to evaluate safety.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 584 women (84%) and 115 men (16%) participated in the clinical trial.

FDA Clinical  Review

Figure 2 summarizes the percentage of patients by race in the clinical trials used to evaluate safety.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 680 White (97%), 7 Black or African American  (1%) and 12 Other (2%)

*Other includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander

FDA Clinical Review

Figure 3 summarizes the percentage of patients by age in the  clinical trials used to evaluate safety.

Figure 3. Baseline Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  54 (8%) were 6 months to 3 years, and 338 (48%) patients were 4 - 11 years, 110 (16%) were 5 – 11 years and 197 (28%) were 18 years and older.

FDA Clinical Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trials used to evaluate safety.

Figure 4. Baseline Demographics by Ethnicity

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. In total,  463 (66%) patients were Hispanic or Latino and 236 patients were not Hispanic or Latino (34%).

FDA Clinical Review

How were the trials designed?

The benefit and side effects of XEGLYZE were evaluated in two clinical trials that enrolled patients with head lice who were at least 6 months old.

About half of all enrolled patients was randomly assigned to XEGLYZE and the other half to placebo. XEGLYZE lotion or placebo lotion were applied once as a 10-minute treatment to infested hair. The benefit of XEGLYZE in comparison to placebo was assessed after 1, 7 and 14 days by comparing the counts of patients in each group who were free of live lice.

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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