Study finds spinosad more effective than permethrin in treating head lice

9/30/2009

CARMEL, Ind. ParaPRO on Wednesday announced the results of two phase 3 clinical studies published online this month in the journal Pediatrics, which concluded that a spinosad suspension was significantly more effective in eliminating head lice (pediculosis capitis) than permethrin. Permethrin, which is marketed under the brand name Nix (marketed by Insight Pharmaceuticals and available over the counter), is the American Academy of Pediatrics’ recommended first-line medication for head lice.

The studies, in which the participants used the products at home, unsupervised, demonstrated that 0.9% spinosad was significantly more effective than 1% permethrin lice treatment in eliminating head lice. The majority of spinosad-treated participants were lice-free after only one application. In addition, treatment with spinosad did not require the combing of nits, in contrast to the comparator treatment permethrin (which was used according to its label instructions and required nit removal by combing).

“This is significant because convenience and compliance are important issues in treating and getting rid of head lice,” stated Dow Stough, Burke Pharmaceutical Research and an investigator in the studies.

Both the spinosad and permethrin treatments were well tolerated with few adverse events reported.

Results of these and other studies have been submitted to the Food and Drug Administration for approval to market spinosad suspension as a prescription product. ParaPRO is seeking approval to market the product under the name NatrOVA.

ParaPRO licensed spinosad from Eli Lilly and Co. in 2002 for the treatment of head lice. Since then, ParaPRO has developed a proprietary formulation and tested the product and is currently awaiting FDA review.

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