PHILADELPHIA, Feb. 22, 1996 -- SmithKline Beecham (NYSE: SBE, SBH) announced today that Famvir(R) (famciclovir), the first new drug cleared to treat genital herpes in more than a decade, is now available nationwide. Famvir, an antiviral drug that requires less frequent dosing than the medication commonly used to treat genital herpes, is indicated for the treatment of recurrent genital herpes in immunocompetent patients.
In clinical trials, Famvir, only twice daily, significantly reduced genital herpes symptoms, collectively defined as pain, tenderness, burning, itching and tingling, in patients treated within six hours of symptoms or lesion onset. Famvir also accelerated the healing of herpes lesions and reduced viral shedding.
"Famvir offers patients and physicians an effective alternative for relieving the pain and discomfort associated with genital herpes," said Stephen Sacks, M.D., F.R.C.P.(C), a professor of medicine at the University of British Columbia in Vancouver. "Famvir can be taken less often -- twice daily for five days -- and therefore offers patients greater convenience. Because the incidence of genital herpes is growing at an alarming rate, new treatment options are needed."
It is estimated that at least 31 million Americans, or one in six adults, have genital herpes, a sexually transmitted disease spread through sexual contact with an infected partner. Genital herpes is a contagious and recurrent viral infection caused by the herpes simplex virus (HSV). Each year, an estimated 500,000 new cases of genital herpes occur, and prevalence is reaching epidemic proportions. The prevalence of HSV-2 antibody in Americans ages 15 to 74 increased 32% from 1978 to 1990.
"A 32% increase in genital herpes over a 12-year period is a startling statistic," says Peggy Clarke, president of the American Social Health Association (ASHA), a nonprofit organization dedicated to stopping sexually transmitted diseases. "Since each person with recurrent herpes is able to infect any number of others, at some point, the mathematical dynamics of this epidemic will become overwhelming."
Despite these epidemic proportions, the public does not recognize the prevalence of genital herpes. According to a recent Gallup survey, only 17% of people in six Western countries named genital herpes when asked to name STDs other than AIDS. Among U.S. respondents, the vast majority believe that the prevalence of genital herpes is on the order of 1 in 1000 or 1 in 500 or 1 in 100. Only 2% correctly guessed the actual prevalence. In the U.S. alone, up to 80 percent of the patients with genital herpes suffer from symptomatic recurrences of the disease following an initial outbreak. During a recurrence of genital herpes, patients may experience painful sores, as well as tenderness, burning, itching and tingling in the genital area. Those infected can spread the disease to others through viral shedding, the time in which the patient is infectious; viral shedding can occur with or without lesions or symptoms. Many patients with genital herpes experience an average of five outbreaks -- or recurrences -- per year, although some may have recurrences as often as every month.
Unlike the most commonly used therapy for recurrent episodes, which needs to be taken frequently -- 200 mg tablets five times daily for five days -- and can be inconvenient for the patient, Famvir's dosage for recurrent episodes of genital herpes is 125 mg twice daily for five days and should be initiated at the first sign or symptom.
"Famvir can be taken less often. It has high bioavailability, that is, more of the drug is absorbed (77%) and available for use by the body," says Dr. Sacks, a recognized expert in herpetic infections and author of The Truth about Herpes.
Famvir received FDA clearance for the treatment of recurrent genital herpes in December 1995. Famvir has been marketed in the United Kingdom for the treatment of first episode and recurrent genital herpes since April 1995. It is currently approved in nearly 40 countries for the treatment of acute shingles (herpes zoster) and was cleared for marketing in the U.S. in June 1994. As with other antivirals, Famvir does not reduce the incidence of post-herpetic neuralgia. However, Famvir was proven to reduce the duration of post-herpetic neuralgia, the chronic, often debilitating pain that persists after shingles lesions have healed. Famvir also is being studied for a number of other herpesvirus infections. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufacturers, and markets pharmaceuticals, vaccines, over-the-counter medicines, health-related products, and provides clinical laboratory testing services, disease management and pharmaceutical benefit management.
CONTACT: Sharyn Arnold of SmithKline Beecham, 215-751-7074 (SBE SBH)
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