Jan. 19, 2011 -- The FDA has approved a new treatment for controlling head lice, called Natroba Topical Suspension 0.9%, and says the substance can be safely used for infestations in children as young as age 4, as well as in older youths and adults.
The manufacturer, ParaPro LLC of Carmel, Ind., says that one application of the treatment, an insecticide, can resolve most problems with head lice in about 10 minutes.
Head lice feed several times daily on human blood and can be found on peoples’ heads and in their eyebrows and eyelashes. Head lice are annoying but are not known to cause disease.
They are spread mainly by direct head-to-head contact. The tiny bugs move by crawling and can easily pass from child to child because kids play closely together, often in large groups. Lice also are spread by sharing of hats, combs, brushes, or towels, and can affect all age groups.
“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” Julie Beitz, MD, of the FDA’s Center for Drug Evaluation and Research, says in a news release. “Head lice is a common problem among school children in the United States.”
The FDA says that Natroba’s safety and effectiveness have been established in two studies.
The agency says 552 people received a 10-minute treatment with Natroba, and that if live lice were seen a week later, another application was tried. The percentage of participants who were lice free after the final Natroba treatment was 86%, compared to 44% in a comparison group.
The agency says safety of Natroba (spinosad) has not been established for children under age 4, and therefore the topical treatment isn’t approved for kids younger than that.
The FDA cautions that the product should not be used in infants because it contains benzyl alcohol, which has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.
ParaPro says in a news release that the medication will become available in the first six months of 2011.
“We believe Natroba gives physicians and parents a game-changing solution to the problem of head lice,” Bill Culpepper III, president of the ParaPro, says in the company’s news release. “Natroba is the only head lice treatment whose approval is supported by superiority studies versus permethrin 1%.” Permethrin 1% is a lotion used to treat head lice.
Culpepper says the FDA’s approval of Natroba is “a significant step forward in the longstanding struggle to treat head lice infestations and we look forward to making the product available in pharmacies nationwide as soon as possible.”
Unlike treatments now available, he says, most children who use Natroba will need only one application and won’t be forced “to sit through extensive, time-consuming nit combing sessions.”
The CDC estimates that 6 million-12 million cases of head lice infestation occur annually among children ages 3 to 11.