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FDA approves topical lice treatment spinosad for patients aged 4 years and older
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The FDA has approved the topical application of spinosad for treating head lice in patients 4 years of age and older.
The FDA’s approval was based on two phase 3, multicenter, active-controlled, randomized studies, in which approximately 86% of patients treated with 0.9% spinosad (Natroba, ParaPro) were lice-free after 14 days vs. 44% of control patients.
The most common adverse events included application site redness, application site irritation and eye irritation. Spinosad is not approved for pediatric patients younger than 4 years of age; in particular, the FDA warned that the product not be used in neonates and infants younger than 6 months because it contains benzyl alcohol, which has been associated with serious adverse events in these populations.
Since spinosad does not require nit combing and can be used unsupervised at home, researchers concluded that it “will provide an effective and more convenient method for treating a lice infestation.” Permethrin currently is the AAP-recommended first-line lice treatment.
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