The FDA has approved Sklice (ivermectin) lotion 0.5% for the topical treatment of head lice in patients 6 months of age and older, according to Sanofi.
Sklice lotion, which treats lice in most patients with a single, 10-minute application of the lotion—without nit combing—will be commercialized by Sanofi Pasteur U.S.
"The approval of Sklice lotion provides physicians and parents with a new treatment option for head lice, a condition that is notoriously frustrating to treat," said Kenneth P. Guito, general manager, Sanofi-Topaz. "Through a unique mode of action, Sklice lotion resolves most head lice infestations in one application, and is very well tolerated."
Formulated with ivermectin, an antiparasitic that has been used orally for more than 20 years and more than 1 billion times to treat other parasites, Sklice lotion was developed to meet the demand for an effective, convenient head lice treatment that is well tolerated in children.
"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," said Dr. Bill Ryan, BVSc, consultant to Sanofi Pasteur U.S., who led the clinical trial programs for the lotion.
The FDA approval of Sklice lotion was based on results of two identical, randomized, double-blind phase III clinical trials that compared the lotion with a vehicle control (placebo) in 781 patients from the U.S. 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.