FDA approves head lice treatment for children and adults

January 28, 2011

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older.

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older. Natroba is a topical drug product and should be applied only to the child’s scalp or hair

The safety and effectiveness of Natroba Topical Suspension 0.9 % has been established in 2 multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment of the drug. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free 14 days after the final treatment of Natroba was approximately 86% compared to 44% of the control group. Common adverse events reported include redness or irritation of the eyes and skin.

“We believe Natroba gives physicians and parents a game-changing solution to the problem of head lice,” said Bill Culpepper III, president of ParaPRO, LLC, in a company press release. “Natroba is the only head lice treatment whose approval is supported by superiority studies versus permethrin 1%. FDA approval of Natroba is a significant step forward in the long-standing struggle to treat head lice infestations, and we look forward to making the product available in pharmacies nationwide as soon as possible. Unlike many other currently available treatments, most children will only require one application and do not need to sit through extensive, time-consuming nit combing sessions when Natroba is used. This means that parents trying to rid their children of head lice will soon have an important new treatment option given the ease of use and effectiveness of Natroba.”

Until Natroba was approved, the most common pediatrician-recommended head lice treatments available either over-the-counter or by prescription required nit combing, which can be painstaking and time consuming.

“Although there are some OTC and prescription products now available in the United States, this new product does provide a different option for the common problem of head lice among school-age children,” said F. Randy Vogenberg, PhD, RPh, strategic pharmacy advisor, Business Group Pharmacy Collaborative, Greenbelt, Md., and Sharon, Mass., and senior fellow, Jefferson School of Population Health, Philadelphia. “For warmer climate states, this will be particularly useful year round.”

Safety in pediatric patients younger than 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Related Content:

Pediatrics | News