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Pernix Therapeutics Holdings, Inc. (“Pernix”) (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, and ParaPRO, LLC today announced the commercial launch of Natroba™ (spinosad) Topical Suspension, 0.9%, an FDA-approved prescription treatment for head lice in patients four years of age and older.
Natroba™ treats head lice using spinosad, a compound derived from a soil microbe. Natroba™ is a novel therapy that showed superior efficacy against permethrin 1% in clinical trials without nit combing, which can be very tedious and time consuming. In phase III clinical studies
(1), Natroba™ was shown to be more effective at eliminating head lice infestations than permethrin 1%.
The U.S. Centers for Disease Control and Prevention estimates there are between 6 to 12 million cases of head lice infestations each year in the United States with most cases occurring in children ages 3 to 12 years old.
“The launch of Natroba™ is another significant milestone for our Company as we continue to diversify our product portfolio,” said Cooper Collins, President and Chief Executive Officer of Pernix. “Natroba™ is an important new, easy to use and effective treatment option for parents of children suffering from a head lice infestation. We are pleased that the product is available for the upcoming school year.”
Pernix co-promotes Natroba™ with ParaPRO, LLC, the developer of the product.
Important Safety Information
Natroba™ contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants.
Natroba is a prescription, topical treatment for use only on the hair and scalp as directed by a physician. The most common adverse events were: application site redness (3%), redness and irritation of the eyes (2%) and application site irritation (1%).