Research Triangle Park, NC, January 3, 2003 -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved ZOVIRAX (acyclovir) Cream for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older). Cold sores, also known as herpes labialis or fever blisters, are highly infectious sores on the lip and outer edge of the mouth.
This is the first approval for the cream formulation in the U.S. ZOVIRAX Cream 5% is a formulation for topical administration and should be applied five times per day for four days. Therapy should be initiated as early as possible following onset of signs and symptoms (i.e., during the prodromeor when lesionsappear).
ZOVIRAX Cream is not a cure for cold sores. In studies, the most common skin-related side effects with ZOVIRAX Cream were local application site reactions, occurring in 5 percent of patients on ZOVIRAX Cream and 4 percent of patients receiving placebo. These reactions included dry or cracked lips, flakiness or dryness of skin, a burning or stinging feeling or itching of the skin. Each event occurred in fewer than 1% of patients.
Biovail acquired exclusive promotion and distribution rights for ZOVIRAX Ointment and Cream for the United States and Puerto Rico in October 2001. The NDA was submitted in March 2002 by GSK. Under the terms of the agreement, GSK will manufacture and supply ZOVIRAX Ointment and Cream to Biovail.
This is the second GSK drug approved this year for the treatment of cold sores. In September, the FDA approved a supplemental new drug application (sNDA) for VALTREX (valacyclovir HCl) caplets for the treatment of cold sores in healthy adults. The approval of this sNDA made VALTREX the first one-day, oral antiviral medication proven to shorten the duration of a cold sore outbreak. While taking VALTREX for cold sores, you should not exceed one day of treatment, two doses taken 12 hours apart.
VALTREX is indicated for the initial and recurrent treatment and for suppression of genital herpesoutbreaks as well as for herpes zosterand cold sores. The most common side effects with VALTREX are headache, nausea, vomiting, abdominal pain and dizziness. VALTREX is intended for adults with normal immune systems. To avoid a potentially serious complication, patients should tell their doctor if their immune system is not normal because of advanced HIV disease, bone marrow or kidney transplant. There is no cure for herpes and even with treatment it may be possible to spread herpes to others.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. U.S. operations are in Philadelphia, PA, and Research Triangle Park, NC.