Age indication of Pediculicide Natroba (spinosad) to include children 6 months and older

CARMEL, Ind. — ParaPRO announced earlier this month that the Food and Drug Administration has expanded the age indication for Natroba (spinosad) topical suspension 0.9% to include children 6 months of age and older who have head lice infestations (pediculosis capitis).

 

“Natroba (spinosad) Topical Suspension 0.9% is the only prescription strength head lice medication proven superior to permethrin 1% (brand name Nix) in Phase III trials,” stated Bill Culpepper, president of ParaPRO. “The FDA approval for an indication in patients as young as 6 months of age, plus spinosad’s lack of systemic absorption and Natroba’s pregnancy category B classification, completes our desired safety profile for Natroba.”

 

“ParaPRO developed Natroba in direct response to an increase in lice resistance to current permethrin over-the-counter therapies," Culpepper said. “An approved age indication down to 6 months is timely given that recent U.S. head lice resistance is as high as 99.6%, according to a 2014 article in the Journal of Medical Entomology.”

 

Natroba treats head lice using spinosad, a compound derived from a soil microbe. In the clinical trials, patients treated with permethrin 1%, more often required an additional round of treatment than patients who were treated with Natroba, the company stated.

 

Natroba received approval in 2011 as a prescription medication. It is an effective, easy‐to‐use product that does not require nit combing, the company stated.