Medication Monitor

Generic Name (Trade Name—Company)
February 1, 2011


Treatment for head lice


Treatment of head lice infestations in patients 4 years of age and older

This new prescription 0.9% topical suspension lice product is derived from a soil microbe. In two Phase III clinical trials involving 1,038 patients, 84.6% (study 1) and 86.7% (study 2) of patients treated with spinosad were lice free 14 days after the last treatment, compared with 44.9% (study 1) and 42.9% (study 2) of patients treated with permethrin 1% (Nix—Insight), FDA said. The most commonly reported adverse events with spinosad were application-site erythema (3%), ocular hyperemia (2%), and application-site irritation (1%). Spinosad is recommended to be applied to dry scalp and hair, left in place for 10 minutes, and rinsed off with warm water. No nit combing is required. Repeat applications are needed only if live lice are seen 7 days after the first treatment. ParaPRO expects spinosad to launch in the first half of 2011.