To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Denavir Antiviral Cream For Treatment of Cold Sores Cleared by FDA URL: http://www.pslgroup.com/dg/C9CE.htm Doctor's Guide September 25, 1996
PITTSBURGH, Sept. 25, 1996 -- Denavir(TM) (penciclovir cream), a new treatment for recurrent cold sores (herpes labialis) in healthy adults, is cleared for marketing by the U.S. Food and Drug Administration (FDA), SmithKline Beecham (NYSE: SBH) announced today. It is the first and only topical antiviral cream to be cleared by the FDA for this indication. Denavir will be marketed by SmithKline Beecham Consumer Healthcare and will be available by prescription. Denavir was recently launched in the United Kingdom under the brandname Vectavir(TM) for the treatment of cold sores and is currently under review by regulatory authorities in other major countries. Denavir contains penciclovir which is active against the herpes simplex virus, the cause of cold sores. Penciclovir is also the active ingredient in Famvir(R) (famciclovir), SB's oral medication for the treatment of shingles (herpes zoster) and recurrent genital herpes. In the two largest clinical trials in patients with cold sores conducted to date, Denavir was shown to significantly reduce the duration of lesion pain and speed lesion healing. It was well tolerated. The most frequently reported side effects for both Denavir and placebo were headache and mild skin irritation. The only products previously marketed for cold sores in the US are over-the-counter (nonprescription) preparations which only moisturize and/or relieve pain. "On all important clinical parameters, Denavir was significantly better than placebo in treating cold sores," said Spotswood L. Spruance, MD, Department of Medicine, at the University of Utah School of Medicine, Salt Lake City, and lead investigator in the clinical studies involving more than 3000 patients. "Denavir should be initiated at the first symptom, such as tingling, or first sign, such as swelling. It is the first topical antiviral treatment to convincingly affect the clinical course of recurrent cold sores. After 25 years of research into the management of cold sores, now there is a product that clearly impacts this disease." Cold sores affect an estimated 40 million Americans each year with a rate of frequency which varies from rare episodes to 12 or more recurrences per year. Most sufferers experience one to three attacks annually. Cold sores generally appear around the mouth and on the lips. The virus can be activated by many factors including the sun (ultraviolet light), fever, menstruation and stress. The signs and symptoms of cold sores usually begin with tingling discomfort or itching leading to lesions which eventually rupture and then begin to dry, forming a thin yellowish crust. Healing of the blisters is usually complete by 8 to 10 days after onset if untreated. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.