Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion treats lice in most patients with a single 10-minute application of the lotion, without nit combing.
"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."
Sklice will be commercialized by Sanofi Pasteur U.S., an established leader in the pediatric area with an extensive heritage of bringing innovative solutions to the pediatric healthcare community. "We are pleased that Sanofi Pasteur – through our longstanding relationships with pediatric professionals -- can help address the burden of head lice by bringing a well-tolerated, effective, single application treatment option to patients 6 months and older," added Chad Hoover, Vice President and Chief Commercial Officer, Sanofi Pasteur U.S.
Each year in the United States, head lice infest an estimated 6 to 12 million children aged 3 to 11 years. Estimates for direct and indirect costs, which include millions of lost school days and lost work for parents, are as high as 1 billion dollars.
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 works differently and 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," 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.