Sanofi Pasteur, the vaccines division of Sanofi, announces that Sklice® (ivermectin) Lotion, 0.5 percent, is now commercially available by prescription in U.S. pharmacies for the topical treatment of head lice infestations in patients 6 months of age and older, in the context of an overall lice management program.
Head lice cases have been rapidly increasing in the United States, affecting an estimated 6 to 12 million children aged 3 to 11 years each year.
Sklice Lotion was developed to meet the demand for an effective head lice treatment option that is well-tolerated in children 6 months of age and older. In phase 3 trials, Sklice Lotion was proven to resolve most head lice infestations with one well-tolerated, 10-minute application. Two weeks following initial treatment, 71 percent to 76 percent of patients treated with Sklice Lotion were lice-free. Fewer than 1 percent of patients experienced side effects which included eye redness or soreness, eye irritation, dandruff, dry skin and burning sensation of the skin.
Sklice Lotion should be used in the context of an overall lice management program, which includes washing (in hot water) or dry-cleaning all recently worn clothing, hats, used bedding and towels, as well as washing personal care items such as combs, brushes and hair clips in hot water. No nit combing is required; however, if desired, a fine-tooth comb may be used to remove dead lice and nits.
Sklice Lotion is being commercialized by Sanofi Pasteur U.S., an established leader in the pediatric marketplace with an extensive heritage of bringing innovative solutions to the pediatric healthcare community.
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.
Developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October 2011, Sklice Lotion was approved by the U.S. Food and Drug Administration (FDA) in February 2012.
Sklice Lotion is only available by prescription. Parents must contact their healthcare provider before going to the pharmacy.