September 10, 2002 GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VALTREX® (valacyclovir HCl) caplets for the treatment of cold sores in healthy adults, making VALTREX the first one-day, oral antiviral medication proven to shorten the duration of a cold sore outbreak. Cold sores, also known as herpes labialis or fever blisters, are highly infectious sores on the lip and outer edge of the mouth.
“This approval means that cold sore sufferers now have a one-day, oral medication available which shortens the duration of the disease by blocking growth of the virus,” said Spotswood L. Spruance, M.D., University of Utah School of Medicine in Salt Lake City.
Only VALTREX offers the convenience of once-daily dosing for the suppression of genital herpes outbreaks, as well as a three-day treatment for recurrent outbreaks of genital herpes. Cold sore sufferers can now experience the convenience of a one-day treatment with VALTREX. Treatment with VALTREX should be initiated at the first symptom of a cold sore. The efficacy of VALTREX has not been established when treatment is initiated after the development of clinical signs of a cold sore. Treatment should not exceed one day.
“When I have a cold sore, I just want it to heal as quickly as possible,” said Rhonda Compton, a long-time cold sore sufferer. “I am excited to know there is finally a treatment that will not only shorten the duration of my outbreak, but also is as simple as taking medicine for just one day.”
ABOUT COLD SORES It is estimated 20-40 percent of the adult population has had a cold sore at some point.1 Cold sores are caused by the herpes simplex virus (HSV), the most common cause being HSV-1. Commonly referred to as fever blisters, cold sores are ulcers or blisters on the lip. Many people say they feel a "tingle" or "prodrome" before the blisters actually form. Cold sores, like other herpes infections, are most contagious from the first "tingle" until the blister is completely healed. People with cold sores are advised to avoid kissing or contact with the sores and to wash their hands immediately after touching the sore.
While the majority of the population has been exposed to HSV-1, not everyone develops cold sores. It is unknown why some people get cold sores while others do not. There are certain things that trigger cold sores, including stress, a cold, fever or the flu, being run-down or exposure to the sun. After being “triggered,” the herpes simplex virus begins to reproduce, resulting in damage to skin cells which can lead to the characteristic blisters.
ABOUT THE STUDIES Two double-blind, placebo-controlled studies enrolled 1,856 subjects with a history of recurrent cold sores. Subjects were instructed to initiate treatment at the first sign or symptom of the cold sore. Subjects took either two grams of VALTREX twice a day for one day and placebo on day two, two grams of VALTREX twice a day on day one and one gram of VALTREX twice a day on day two, or placebo for two days. The mean duration of the cold sore was about one day shorter with VALTREX than with placebo. There was no difference between the one day and two day treatment groups. Side effects for VALTREX versus placebo included headache (VALTREX 14% vs. placebo 10%) and dizziness (VALTREX 2% vs. placebo 1%). These studies demonstrate that VALTREX two grams twice a day for one day significantly shortens the duration of a cold sore outbreak.
VALTREX also is indicated for the initial and recurrent treatment and for suppression of genital herpes outbreaks as well as for herpes zoster. The most common side effects with VALTREX are headache, nausea and abdominal pain. 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. headquarters are in Philadelphia, Pa., and Research Triangle Park, N.C. 1. Spruance SL (1995). Herpes simplex labialis. In SL Sacks et al., eds., Clinical Management of Herpes Viruses, pp. 3-33. Washington, DC: IOS Press.