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Published on 3/3/2006 in the Prospect News Biotech Daily.

Novartis' Famvir speeds healing time of cold sores, genital herpes, study says

By Lisa Kerner

Erie, Pa., March 3 - Novartis Pharmaceuticals Corp. said that new data presented at the American Academy of Dermatology annual meeting demonstrated that a single dose of the company's prescription antiviral Famvir (famciclovir tablets) given to patients with recurrent cold sores within one hour of the onset of symptoms resulted in significant improvements in healing time and resolution of pain and tenderness.

This is the first study of its kind to show the benefit of administering a full course of antiviral therapy in a single dose when the virus is most active, according to a Novartis news release.

A second study presented at the meeting showed that Famvir is the first and only antiviral treatment that demonstrated that a single day of therapy is effective in the treatment of recurrent genital herpes, the company said.

Both studies were multicenter, multinational, randomized, double-blind and placebo controlled.

In the first study, which compared single-dose Famvir (1500mg orally once) or single-day Famvir (750mg orally twice) to placebo, Famvir reduced the time to healing of primary vesicular lesions by two days, according to the release.

The study also showed that Famvir reduced time to return to normal skin by two days and reduced time to resolution of pain and tenderness in patients with lesions by one day.

Novartis said Famvir was shown to be well-tolerated and had a safety profile similar to placebo.

In the second study of single-day Famvir (1000mg orally twice) compared to placebo, Famvir, when given to patients within six hours of an outbreak, reduced the time to healing of non-aborted lesions by two days. Famvir was also shown to reduce the duration of symptoms such as burning, tingling, itching, pain and tenderness.

Novartis said it filed a supplemental New Drug Application with the Food and Drug Administration based on the studies' findings in the fall of 2005.

"We are committed to helping herpes sufferers manage this chronic, recurring condition," Novartis senior clinical research physician Kamal Hamed said in the release.

"The results of these studies revealed Famvir to be an effective, convenient treatment option that helps lessen or reduce the duration of cold sore and genital herpes outbreaks."

Novartis is based in East Hanover, N.J., and researches, develops, manufactures and markets prescription drugs used to treat cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory diseases and conditions.


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