Source: FDA, National Drug Code (US) Revision Year: 2019
In vitro studies of the effect of ULESFIA Lotion on native, captured lice suggest that benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.
The absorption of benzyl alcohol from ULESFIA Lotion was evaluated in 19 subjects with head lice infestation. Subjects were divided into two age groups: 6 months to 3 years and 4 to 11 years. ULESFIA Lotion was applied for an exaggerated exposure period (3 times the normal exposure period). Benzyl alcohol was quantified in a single plasma sample in 4 out of 19 subjects (21%): three subjects in the 6 months to 3 years age group at 0.5 hour post-treatment (ranging from 1.97 to 2.99 mcg/mL) and one subject in the 4 to 11 year age group (1.63 mcg/mL) at 1 hour post-treatment out of a total of 102 samples analyzed.
Long-term studies in animals to evaluate carcinogenic potential of ULESFIA Lotion have not been conducted. No evidence of carcinogenic activity was noted for benzyl alcohol in 2 year oral carcinogenicity studies in rats (doses up to 400 mg/kg benzyl alcohol) or mice (doses up to 200 mg/kg benzyl alcohol) conducted by the National Toxicology Program.
Benzyl alcohol has produced mixed results in genetic testing. Benzyl alcohol was negative in the Ames test with and without metabolic activation, sex-linked recessive lethal assay, and a replicative DNA synthesis assay (conducted in male rats). Negative results were obtained in the mouse lymphoma assay with metabolic activation, but a positive response was noted in the mouse lymphoma assay without metabolic activation at a concentration producing a high level of cellular toxicity. Benzyl alcohol was positive in the Chinese hamster ovary chromosomal aberration assay with metabolic activation.
No fertility studies have been conducted with benzyl alcohol.
Two multicenter, randomized, double-blind, vehicle-controlled studies were conducted in 628 subjects 6 months of age and older with active head lice infestation. For the evaluation of efficacy, the youngest subject from each household was enrolled in the Primary Treatment Cohort with ULESFIA Lotion or vehicle. Other infested household members were enrolled in a Secondary Treatment Cohort and received the same treatment as the youngest subjects. The Secondary Treatment Cohort was not included in the efficacy analysis, but was evaluated for all safety parameters.
In Study One, 125 Primary Treatment Cohort Subjects were randomized to ULESFIA Lotion (N=63) and vehicle (N=62). Study Two enrolled 125 Primary Treatment Cohort Subjects: 64 randomized to ULESFIA Lotion and 61 to vehicle. Treatment was applied two times separated by one week.
Efficacy was assessed as the proportion of subjects who were free of live lice 14 days after the final treatment. Subjects with live lice present at any time after first treatment were considered to be treatment failures. Table 4 contains the proportion of subjects who were free of live lice in each of the two trials.
Table 4. Proportion of Subjects Free of Live Lice 14 Days After Last Treatment:
| ULESFIA LOTION | Vehicle | |
|---|---|---|
| Study 1 | (N=63) 48 (76.2%) | (N=62) 3 (4.8%) |
| Study 2 | (N=64) 48 (75.0%) | (N=61) 16 (26.2%) |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
