Tuesday, April 14, 2009

Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

(BUSINESS WIRE)--Sciele Pharma, Inc., a Shionogi Company, today announced that the U.S. Food & Drug Administration (FDA) has approved Benzyl Alcohol Lotion 5%, the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Sciele acquired from Summers Laboratories the rights to this novel, patented product in the United States, Canada and Mexico. The Company expects to launch the product in the third quarter of 2009, in time for peak head lice season.

“We are excited to introduce this novel product to the prescription head lice treatment market. This product will meet the unmet need for an effective treatment that does not contain a neurotoxic chemical and addresses possible resistance issues,” said Ed Schutter, President and Chief Operating Officer of Sciele Pharma. “The approval of this new head lice product marks an important milestone for Sciele’s pediatric portfolio.”

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. The mechanism of action of Sciele’s product is facilitated through the use of benzyl alcohol which prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

“Head lice are an all-too-common and challenging medical problem that causes anxiety in families, schools and summer camps,” said Ira A. Pion, MD, Clinical Assistant Professor, Department of Dermatology, New York University Medical Center. “Sciele’s new product should be welcomed by health professionals and parents as a safe and effective treatment option that treats children with head lice without the use of harsh chemicals and addresses concerns about the increased resistance of lice to therapies that contain neurotoxic chemicals.”

Sciele is working with professional organizations, such as the National Association of School Nurses, to educate health professionals and the public about head lice. The Company has assembled a national advisory board of leading head lice experts from various medical specialties (pediatrics, dermatology, family practice and clinical research) to provide guidance on these efforts. Full prescribing information is available at www.sciele.com.

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