GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Valtrex (valacyclovir HCl) caplets for suppressive therapy in otherwise healthy adults with genital herpes in order to reduce the risk of heterosexual transmission of genital herpes (GH). The study of 1,484 couples conducted in support of the application showed that once-daily suppressive therapy with Valtrex, in addition to counseling on safer sex practices, reduced the risk of transmission of symptomatic genital herpes (signs or symptoms of GH) by 75 per cent and reduced the risk of overall acquisition of the virus by 48 per cent. Safer sex practices should always be used with suppressive therapy.

"As a physician who's been treating patients suffering with herpes for years, I have consistently heard from my patients that fear of giving this disease to their partner is a major concern. This approval gives patients another tool, in addition to safer sex practices, to help them protect their partners," said Larry Corey, lead study investigator and professor, Laboratory Medicine and Medicine, University of Washington and head of the Program in Infectious Diseases, Fred Hutchinson Cancer Research Center. "Now, in addition to safer sex practices, patients with herpes can take once-daily Valtrex to reduce their own outbreaks and, at the same time, protect their partner."

While genital herpes is not a life-threatening disease, once infected, the virus never leaves the body, making it a lifelong condition that can recur at various times with or without symptoms. The virus is generally spread through skin-to-skin contact during sexual activity and often during times when there are no visible signs of a herpes outbreak. In fact, in clinical studies, the majority of people got GH from a partner who knew they had GH but reported no signs or symptoms at the time of recent sexual activity.

"When you're diagnosed with a lifelong disease like herpes, you have so many questions and concerns, including how is it going to affect my relationship and how can I avoid spreading it to my husband," said Cecilia McCracken, a genital herpes sufferer who participated in the study. "However, with this approval today, my husband and I both have more comfort knowing we're doing what we can to reduce the risk."

The approval follows a unanimous (13-0) recommendation by an FDA Advisory Committee on May 14, 2003, to approve suppressive therapy with Valtrex for reducing the risk of transmission of genital herpes in otherwise healthy, heterosexual individuals.