FDA Approves New Treatment for Pediculosis

On January 18, 2011, the U.S. Food and Drug Administration announced approval of Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation, also known as pediculosis, in patients who are 4 years of age and older. While head lice are an especially common problem among school children in the United States, patients at nursing homes are also at high risk of pediculosis. The FDA’s approval of Natroba Topical Suspension 0.9% was based on the observed safety and effectiveness of this treatment in two multicenter, randomized, active-controlled studies that included 552 subjects who received a 10-minute treatment with Natroba. Study participants received a second treatment if live lice were seen a week later. The proportion of subjects who were lice-free 14 days after the final treatment of Natroba was approximately 86% compared with 44% of controls. Common adverse events reported with Natroba included redness or irritation of the eyes and skin. Natroba should be applied only to the scalp or hair and used exactly as prescribed by a healthcare professional. Natroba is manufactured for ParaPRO, LLC, Carmel, IN.