First one-day, oral antiviral for cold sores is approved.

GlaxoSmithKline announced that the U.S. Food and Drug Adminis-tration has approved a supplemental new drug application (sNDA) for VALTREX[R] (valacyclovir HCI) caplets in the treatment of cold sores in healthy adults. 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.

Valtrex offers 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 this medicaton. Treatment should be initiated at the first symptom of a cold sore. Efficacy has not been established when treatment is initiated after the development of clinical signs of a cold sore. Treatment should not exceed one day.

About Cold Sores

It is estimated 20-40% 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 that can lead to the characteristic blisters.

(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.