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New Study Shows One Single Dose of Famvir Significantly Reduces Time to Heal Cold Sore Lesions

First reported clinical trial demonstrating single dose efficacy of an oral anti-viral in treating herpes labialis

DORVAL, QUEBEC -- November 9, 2005 -- Treatment with one single, 1500 mg dose of Famvir*(famciclovir) reduced healing time of herpes labialis lesions (cold sores) significantly faster than treatment with placebo, as revealed by a study presented at the 12^th Annual Meeting of the International Herpes Management Forum in Lisbon, Portugal.

"Patients with recurrent herpes labialis experience discomfort and even pain, not to mention embarrassment and a reduction of quality of life in the more serious cases," says Charles Lynde, MD, FRCPC, Assistant Professor of Medicine the University of Toronto and Staff Dermatologist at Toronto Western Hospital in Toronto. "For this reason it is important to reduce healing time as much as possible. This study shows that Famvir* is significantly more effective than placebo while its single-dose treatment provides convenience without reducing efficacy."

This is the first reported clinical trial for herpes labialis demonstrating single dose efficacy of an oral anti-viral. The randomized, double-blind, placebo controlled, multi-centre study was performed to assess the efficacy and safety of a famciclovir 1500 mg single dose or a famciclovir 750 mg dose taken twice in one day, versus placebo in adult patients with recurrent herpes labialis.

Patients initiated therapy within 1 hour of onset of symptoms, returned to the clinic within 24 hours and continued to visit the clinic for three consecutive days. Thereafter, the patients returned every other day until lesion healing or on day 14, whichever came first.

In summary, a single dose of famciclovir (1500 mg) administered within the first hour of onset of prodromal symptoms resulted in statistically significant differences, as compared to placebo. Specifically, there was a shorter time to healing of vesicular herpes labialis lesions (by ~ 2 days), shorter time to return to normal skin (by ~ 2 days) and faster resolution of pain and tenderness (by ~ 1 day).

It is estimated that 20 per cent of the population gets cold sores, and seven per cent have two or more annually. Cold sores are usually caused by reactivation of latent herpes simplex virus Type I (HSV-1) which can be triggered by stress, low resistance due to illness, exposure to ultraviolet rays of the sun, menstruation, fatigue, as well as trauma or injuries to the mouth.

About Famvir*
Famvir* (famciclovir) is indicated for the treatment of acute herpes zoster (shingles) as well as to treat or suppress recurrent episodes of genital herpes in immunocompetent adults.

Famvir* is also indicated for the treatment of recurrent episodes of herpes simplex infections in HIV-infected patients.

Market authorization for use of Famvir* in the treatment of herpes labialis has not yet been obtained.


SOURCE: Novartis Pharmaceuticals Canada

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