ParaPRO, LLC announced today the results of two Phase III clinical studies published online this month in the journal Pediatrics (Pediatrics 2009; 124:e389-e395) 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, 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 time consuming, rigorous combing of nits (head lice eggs), in contrast to the comparator treatment permethrin (which was used according to its label instructions and required nit removal by combing). Both the spinosad and permethrin treatments were well tolerated with few adverse events reported.
“In these studies, spinosad eliminated head lice for most patients the first time. This meant these caregivers only needed to apply a single treatment and did not need to spend time combing out nits in order to complete the treatment,” said Dow Stough, M.D., Burke Pharmaceutical Research and an investigator in the studies. “This is significant because convenience and compliance are important issues in treating and getting rid of head lice.”
The U.S. Centers for Disease Control and Prevention estimates that there are between 6 to 12 million cases of head lice infestations each year. Most occur in children 3 to 12 years old. Head lice are tiny, wingless insects that live on the human scalp and spread between people by head-to-head contact or the sharing of hats, combs, brushes or towels. In most cases, infestations are not linked to poor hygiene; therefore, they can occur in anyone. Adult head lice are about as big as sesame seeds (2-3 mm long) and infest the human head and neck and also attach their nits (eggs) to the base of the hair shaft. Lice move by crawling; they cannot hop or fly.
Costs associated with head lice infestations are estimated to be as high as $1 billion per year in the United States alone. Direct costs include treatments and clinic visits, and indirect costs range from school nurse time to school absenteeism to lost wages.
Currently, there are many head lice treatments available over-the-counter and by prescription. The therapies most commonly recommended by pediatricians require the painstaking removal of nits. If viable nits remain, re-infestation could occur when the eggs hatch.
Results of these and other studies have been submitted to the U.S. Food and Drug Administration (FDA) for approval to market spinosad suspension as a prescription product. ParaPRO is seeking approval to market the product under the name NatrOVA™.
In the Phase III studies, the subjects treated with spinosad were instructed to apply the product to dry hair, leave it on for 10 minutes, and then rinse with water.
Clinical Trial Design
The two Phase III, multi-center, randomized, evaluator/investigator-blinded, parallel-group studies compared 0.9% spinosad without a nit-combing step with 1% permethrin with combing (according to that product’s instructions) in 1,038 boys and girls six months of age and older with pediculosis capitis.5