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. 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. Widespread oral use of ivermectin began in 1987 to control river blindness (onchocerciasis) in humans. More than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by river blindness and other parasitic conditions. Sklice Lotion was developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October, 2011. Sklice Lotion Pivotal Trials The FDA submission for Sklice Lotion included two identical multi-center, randomized, double-blind, vehicle-controlled studies conducted in subjects 6 months of age and older with head lice infestation. Sklice Lotion or placebo was dispensed to all subjects for application to dry hair and scalp followed by a rinsing after 10 minutes, with instructions not to use a nit comb. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (n=289). Other enrolled infested household members received the same treatment as the youngest subject. Subjects were also evaluated for safety and local tolerability.  The primary efficacy was assessed as the proportion of index subjects who were free of live lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application. The secondary efficacy endpoint was the same assessment applied to the other enrolled subjects. Those with live lice present at any time up to the final evaluation were considered treatment failures. Important Safety Information No adverse events occurred at a rate greater than or equal to 1% in placebo-controlled trials using a single 10-minute treatment of Sklice Lotion in 379 patients ages 6 months and older. The most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin and skin burning sensation. The safety of Sklice Lotion has not been established in pediatric patients below the age of 6 months. Sklice Lotion is not recommended in pediatric patients under 6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier and risk of ivermectin toxicity. There are no adequate and well-controlled studies with Sklice Lotion in pregnant women. Sklice Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In order to prevent ingestion, Sklice lotion should only be administered to pediatric patients under the direct supervision of an adult. Following oral administration, ivermectin is excreted in human milk in low concentrations. This has not been evaluated following topical administration. Caution should be exercised when Sklice Lotion is administered to a nursing woman.