Superiority Over Nix®

Spinosad Topical Suspension 0.9% is the only FDA-approved prescription head lice treatment that demonstrated clinical superiority to Nix® (permethrin 1%) in two head-to-head, phase III clinical trials. No nit combing required.2

Chart outlining Spinosad treatment success
Chart outlining Spinosad treatment success

In two multicenter, randomized, controlled clinical studies under actual-use conditions, significantly more patients using Spinosad Topical Suspension 0.9% were lice-free (no live lice, adults or nymphs) 14 days after the last treatment without nit combing compared to permethrin with combing, 84.6% vs. 44.9% and 86.7% vs. 42.9%, respectively (P<0.001).2

Primary Endpoint: The proportion of patients who were lice free (no live lice, adults or nymphs) 14 days after the last treatment with Spinosad Topical Suspension 0.9% without combing vs. permethrin with combing.

Soil microorganism at the center of the safety profile

The active ingredient in Spinosad Topical Suspension 0.9% derives from a naturally occurring soil microorganism3 that differs from neurotoxic agents such as permethrins and pyrethrins4:

Scientific diagram image of how Spinosad works
  • The active compound, spinosad, is not systemically absorbed, even in patients as young as six (6) months of age5
  • Spinosad targets lice and nits where they live, not penetrating beyond the stratum corneum, before sloughing off through the natural process of non-pathologic desquamation (over approximately 14 days)2
    • In a Phase I clinical trial, fourteen (14) subjects 4-15 years of age, applied a single topical (scalp) treatment of spinosad 1.8% (double the active amount of compound in Spinosad Topical Suspension 0.9%) for 10 minutes. Results demonstrated no systemic absorption of spinosad2
  • There is no evidence of neurotoxicity, developmental/reproductive toxicity, immunotoxicity, mutagenicity, or carcinogenicity from spinosad exposure2
Chart outlining most comment adverse events

Spinosad Topical Suspension 0.9% has also demonstrated similar or lower treatment-related AEs than Nix® (permethrin 1%), the leading OTC medication.6

There is no known resistance to the active compound, spinosad, in head lice and cross-resistance with other insecticides has not been reported for spinosad.7