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2003 OCT 2 - (NewsRx.com & NewsRx.net) -- GlaxoSmithKline (GSK) 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 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% and reduced the risk of overall acquisition of the virus by 48%. 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, MD, 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," Corey said.
While genital herpes is not a life-threatening disease, once infected, the virus never leaves the body, ...