MAGNOLIA, Texas and CARMEL, Ind. — Pernix Therapeutics Holdings Inc. and ParaPRO LLC plan to ship Natroba, a topical treatment for head lice, in the first half of this year.
Pernix and ParaPRO said Wednesday that the Food and Drug Administration this week approved Natroba Topical Suspension 0.9% (spinosad) as a prescription medication to eliminate head lice. The product is indicated for the topical treatment of head lice infestations in patients age 4 and older.
The companies noted that Natroba brings a more user-friendly solution to treating head lice. They reported that the product has been shown to resolve most head lice problems in about 10 minutes with just one application and no nit combing.
"We believe Natroba gives physicians and parents a game-changing solution to the problem of head lice," stated Bill Culpepper, president of ParaPRO. "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," Culpepper explained. "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."
Natroba treats head lice using spinosad, a compound derived from a soil microbe. Until the medication was approved, the most common pediatrician-recommended head lice treatments available over-the-counter or by prescription required nit combing, which can be painstaking and time-consuming, according to ParaPRO and Pernix. Also, in the clinical studies, patients treated with permethrin 1% (marketed under the brand Nix) more often required another round of treatment than patients who were treated with Natroba, the companies said.
"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."
The companies reported that head lice are the second-most communicable disease among schoolchildren, after the common cold. The Centers for Disease Control and Prevention estimate that there are 6 million to 12 million cases of head lice each year, mostly in children 3 to 12 years old.
"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," Dow Stough, M.D., of Burke Pharmaceutical Research and an investigator in the Natroba Phase III clinical studies, said in a statement. "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."
