FDA Approved Drugs » 2012
Medical Areas: Dermatology | Pediatrics/Neonatology | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Sanofi Pasteur
Approval Status: Approved February 2012
Treatment Area: head lice
Ivermectin is a broad-spectrum antiparasitic agent that binds selectively to certain ion channels in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane, resulting in paralysis and death of the parasite.
Sklice is specifically indicated for the topical treatment of head lice infestations in patients six months of age and older.
Sklice is supplied as a lotion for topical treatment. Sklice should be applied to dry hair in an amount sufficient (up to one tube) to thoroughly coat the scalp and hair. Leave Sklice on the hair and scalp for 10 minutes and then rinse off with water.
FDA ApprovalThe FDA approval of Sklice was based on two phase III trials. A total of 781 subjects ages six months and older were treated with 0.5% ivermectin cream or placebo applied to dry hair and scalp, followed by a rinsing after 10 minutes. A nit comb was not used. The primary efficacy endpoint was the proportion of subjects who were free of live lice at day 2 and through day 8 to the final evaluation 14 days following a single application. Significantly more subjects in the Sklice Lotion group were louse-free compared to the placebo group: 76% in Study 1 and 71% in Study 2. 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 subjects experienced adverse events.
Adverse events associated with the use of Sklice may include, but are not limited to, the following:
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.
For additional information regarding Sklice or head lice, please visit the products.sanofi.us web page.