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Sanofi Announces FDA Approval Of Sklice® Lotion For The Treatment Of Head Lice

"This single treatment option provides parents with an additional choice to manage a head lice infestation. Helping children get back to school and parents back to work is a win-win situation for all involved," stated Dr. Bill Ryan, BVSc, consultant to Sanofi Pasteur U.S., who led the clinical trial programs for Sklice Lotion.

The FDA approval of Sklice Lotion was based on results of two randomized, double-blind phase 3 clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients from the United States who were 6 months of age and older. Significantly more subjects in the Sklice Lotion group were louse-free, Sklice was well-tolerated and the majority of Sklice-treated patients were lice-free without any nit combing after two weeks. Fewer than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin and skin-burning sensation.

About Head Lice

Head lice are wingless, parasites that feed on human blood and live close to the human scalp. They move by crawling and are mainly spread by head-to-head contact, most commonly among preschool children attending child care, elementary schoolchildren and the household members of infested children. Infrequently, transmission may occur by contact with items recently used by an infested person, such as clothing, brushes, towels or pillows.

Although head lice infestation is not related to cleanliness, patients experience social stigma, embarrassment and low self-esteem. The process of eradicating lice and their nits can be stressful, tedious and costly.

About Sklice Lotion

Sklice Lotion contains a broad-spectrum antiparasitic agent, ivermectin, which was developed from a soil bacterium that produces a family of compounds (avermectins) shown to bind selectively and with high affinity to certain ion channels present in invertebrate nerve and muscle cells but not in mammals. The resulting increased permeability of the cell membrane causes paralysis and death in certain parasites.

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