Today before the opening bell, Pernix Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved Natroba™ (spinosad) Topical Suspension, 0.9% to eliminate head lice (pediculosis capitis). Shown to resolve most head lice problems in approximately 10 minutes with just one application and no nit combing, Natroba™ is expected to hit the market in the first half of this year.

“We believe Natroba™ gives physicians and parents a game-changing solution to the problem of head lice,” stated Bill Culpepper III, president of ParaPRO, LLC. “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 longstanding struggle to treat head lice infestations and we look forward to making the product available in pharmacies nationwide in the first half of 2011. 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™.”

“We are pleased by the FDA’s decision to approve Natroba™,” commented Cooper Collins, President and Chief Executive Officer of Pernix. “This product provides Pernix with a unique opportunity to promote a treatment that has been proven in multiple clinical trials to be more effective than currently available treatments. We look forward to launching this innovative new prescription product to the pediatrics market via our established sales force in the first half of 2011.”

According to the U.S. Centers for Disease Control and Prevention, there are between 6 to 12 million cases of head lice infestations each year, mostly in children 3 to 12 years old. Costs associated with head lice infestations in the U.S. alone are estimated to be as high as $1 billion per year. Direct costs include treatments and clinic visits, while indirect costs range from school nurse time to school absenteeism to lost wages.

“Head lice are a common problem that can affect anyone regardless of where they live. Historically, it has been a time-consuming, frustrating problem for families. Multiple treatments may be required and due to a variety of factors, the initial treatment is often ineffective,” said Dow Stough, M.D., Burke Pharmaceutical Research and an investigator in the Natroba™ Phase III clinical studies. “When available, Natroba™ will offer a safe and effective option. The Phase III studies showed that a single treatment of Natroba™ worked for most patients and with Natroba™ combing is not required. This product will represent a real advance in the treatment of head lice.”