what did the clinical trials show?

in two phase iii clinical studies, treatment with natroba™, which did not include nit combing, was significantly more effective in eliminating head lice than treatment with permethrin 1%, marketed under the brand name nix®, which does require nit combing and was the head lice treatment recommended by the aap (american academy of pediatrics) at the time the study protocol was approved by the fda.

the article highlighting the two phase iii studies, published online in the journal pediatrics (pediatrics 2009; 124:e389-e395), also discussed the safety and effectiveness of natroba™. the 1,038 participants with active head lice infestations were provided either natroba™(spinosad) topical suspension. 0.9% or nix® to be used at home.

a total of 84.6% (study 1) and 86.7% (study 2) of natroba™-treated participants were assessed to be lice-free 14 days after the last treatment, compared with 44.9% and 42.9% treated with permethrin.
(p < .0001) efficacy was evaluated in the youngest treated patient in each household (n=347).

study 1: treatment success step 2 treatment success

there were few adverse events reported in the phase iii clinical studies. the most commonly occurring adverse events included application-site erythema (redness of the skin) which occurred in 3% of the natroba™ patients (vs. 7% of permethrin), ocular erythema (redness of the eyes) which occurred in 2% of the natroba™ patients (vs. 3% of permethrin) and application-site irritation which occurred in 1% of natroba™ patients (vs. 2% permethrin). although adverse event rates were low for both products, application site redness occurred significantly less frequently in patients treated with natroba™ than in patients treated with permethrin (p = 0.007).

natroba

 

 

 

indication

natroba™ topical suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.

adjunctive measures

natroba™ topical suspension should be used in the context of an overall lice management program:

  • wash (in hot water) or dry clean all recently worn clothing, hats, used bedding and towels
  • wash personal care items such as combs, brushes, and hair clips in hot water

a fine-toothed comb or special nit comb may be used to remove dead lice and nits.

important safety information

natroba™ topical suspension contains benzyl alcohol and is not
recommended for use in neonates and infants below the age of 6 months. systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

consult the patient information, full prescribing information and your doctor for more complete information on natroba™ topical suspension.

you are encouraged to report negative side effects of prescription drugs to the fda. visit www.fda.gov/medwatch or call
1-800-fda-1088.

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