Sciele Pharma, Inc., a Shionogi Company, announced the availability of Ulesfia (Benzyl Alcohol Lotion 5%), the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Approved by the U.S. Food & Drug Administration (FDA), Ulesfia is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia is available now by prescription nationwide in time for peak head lice season.
"We are pleased to introduce Ulesfia during the summer camp months and ahead of the back-to-school period, two settings and seasons when head lice infestations are prevalent and cause anxiety for parents and children," said Ed Schutter, President and Chief Operating Officer of Sciele Pharma. "This novel product delivers on our goal to provide an effective FDA approved head lice treatment that does not contain a neurotoxic chemical and addresses possible resistance issues."
Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice, parasites that survive by injecting small amounts of saliva and removing small amounts of blood from the scalp every few hours(1). To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. Ulesfia's unique mechanism of action is facilitated through the use of benzyl alcohol which prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.
"Outbreaks of head lice are beginning now, when kids are interacting at summer camps, and will peak when they return to school," said Anthony J. Mancini, M.D., FAAP, FAAD, Head, Dermatology, Children's Memorial Hospital and Professor of Pediatrics and Dermatology, Northwestern University's Feinberg School of Medicine. "We are excited to have a new treatment option for this challenging medical problem that is effective without using harsh chemicals, and will not encounter the increasing resistance of lice to therapies that contain neurotoxic chemicals."
Sciele is collaborating with the National Association of School Nurses to help educate health professionals and the public about head lice.
Full prescribing information for Ulesfia (Benzyl Alcohol Lotion 5%) is available here (pdf). Sciele acquired from Summers Laboratories the rights to this novel, patented product in the United States.
About Head Lice
Generally found on the scalp, around the ears and at the nape of the neck, the adult louse is about the size of a sesame seed and can be a yellowish-gray or reddish-brown color(2). Eggs, or nits, are smaller and are silver in color(3). The most common symptom of head lice is head scratching caused by sensitivity to the louse's saliva(1), although red bite marks may also be noticed(2). While lice are not considered an infectious disease, transmission from one individual to another can occur during direct contact or through the sharing of personal items such as hats, helmets, brushes or combs(1). Lice are not a sign of poor hygiene, and they do not transmit disease.
About Sciele Pharma, Inc.
Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs more than 1,000 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.
On October 9, 2008, Shionogi & Co., Ltd. and Sciele Pharma announced the completion of Shionogi's acquisition of Sciele. Sciele is now an indirect wholly owned subsidiary of Shionogi.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of people who need them. In addition, Shionogi is engaged in some new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal.
About Summers Laboratories, Inc.
Summers Laboratories is a privately-held pharmaceutical company specializing in highly-targeted prescription and non-prescription products for pediatric and adult dermatology. Summers' leading brand is Triple Paste(R) Medicated Ointment for diaper rash. According to IRI data, Triple Paste is one of the fastest growing diaper rash treatments in the U.S. Triple Paste and other Summers Labs products are carried nationwide by the largest drugstore chains: Target, Wal-Mart and other major retailers. In addition to the lice asphyxiating product recently acquired by Sciele Pharma, Summers Laboratories is working on developing, licensing or acquiring niche prescription and non-prescription dermatological products.
(1) Frankowski, B.L., Weiner, L.B, the Committee on School Health, the Committee on Infectious Disease (September 2002). American Academy of Pediatrics Clinical Report: Guidance for the Clinician in Rendering Pediatric Care: Head Lice. Pediatrics, 110 (3).
(2) Head Lice Control. Beyond Pesticides/NCAMP fact sheet.
(3) Hansen, R.C (September 2004). Overview: The State of Head Lice Management and Control. Am J Manag Care, 10, S250-S263.
Source
Summers Laboratories, Inc
View drug information on Crestor.
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