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%).
For additional safety information, see the patient and full prescribing information at www.Natroba.com.About Pernix Therapeutics Holdings, Inc. Pernix Therapeutics Holdings, Inc. is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded and generic pharmaceutical products primarily for the pediatric market. The Company manages a portfolio of branded and generic products and Theobromine, a development product candidate. The Company’s branded products include its family of prescription treatments for cough and cold (Brovex®, Aldex® and Pediatex®) and CEDAX® (ceftibuten), an antibiotic for middle ear infections. Pernix also seeks to expand its portfolio of branded products through collaborations such as the co-promotion agreement with ParaPro, LLC to market Natroba™, an FDA-approved topical treatment for head lice. The Company promotes its branded products through an established U.S. sales force. Pernix also markets generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals . Founded in 1996, the Company is based in The Woodlands, TX. Additional information about Pernix is available on the Company’s website located at www.pernixtx.com. About ParaPRO ParaPRO, LLC ( www.parapro.com), based in the Indianapolis, Indiana metropolitan area, is a specialty pharmaceutical company focused on commercializing proprietary products for the pediatric market. ParaPRO is a wholly owned subsidiary of SePRO Corporation ( www.sepro.com) Natroba TM is a trademark of ParaPRO, LLC. (1) The Studies were published online in the journal of Pediatrics (Pediatrics 2009, 124:e389-e395) Cautionary Notice Regarding Forward-Looking Statements The Company wishes to caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. No assurances can be given regarding the future performance of the Company. The Company wishes to advise readers that factors could affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed with respect to future periods in any current statements. The Company does not undertake, and specifically declines any obligation, to publicly update any forward-looking statements to reflect events or circumstances occurring after the date such statements are made.