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Ulesfia

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Ulesfia

CLINICAL PHARMACOLOGY

Mechanism of Action

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.

Pharmacokinetics

The absorption of benzyl alcohol from Ulesfia (benzyl alcohol lotion for topical use) 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 (benzyl alcohol lotion for topical use) 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.

Clinical Studies

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 (benzyl alcohol lotion for topical use) 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 (benzyl alcohol lotion for topical use) Lotion (N=63) and vehicle (N=62). Study Two enrolled 125 Primary Treatment Cohort Subjects: 64 randomized to Ulesfia (benzyl alcohol lotion for topical use) 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%)

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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