Head lice infestations continue to be an issue in today's society, with an increase in economic cost and resistance. Spinosad 0.9% topical suspension was recently introduced in the U.S. market as a novel agent with both pediculicidal and ovicidal activity, approved in children 4 years of age and older for the treatment of head lice infestations. In clinical trials, it has demonstrated effectiveness against head lice with permethrin resistance. In two clinical trials comparing spinosad to permethrin, efficacy was observed in the spinosad-treated groups at 84.6% and 86.7%, respectively, when compared to the permethrin-treated groups (respective values of 44.9% and 42.9%; P < 0.001). Overall, spinosad was well tolerated in clinical trials.