Novartis Pharmaceuticals Corporation Release: Single-Day Famvir Treatment Found To Shorten The Duration Of Recurrent Genital Herpes Outbreaks
WASHINGTON, Dec. 18 /PRNewswire/ -- Results from a new study demonstrated that a single day of treatment with the antiviral Famvir(R) (famciclovir) stopped the progression to a full outbreak or shortened the duration of an outbreak in patients with recurrent genital herpes (RGH). With the completion of this study, Famvir is the only antiviral treatment that has demonstrated that a single day of therapy is effective in the treatment of RGH.
"Current standard of care for recurrent genital herpes is three or five days of oral antiviral therapy. In this study, it is thought that Famvir was effective in a single-day dose because it provided a full course of therapy upfront when the virus is most active," said Dr. Fred Aoki, Professor of Medicine, Medical Microbiology and Pharmacology and Therapeutics, University of Manitoba, and lead investigator in the study. "This is exciting news for physicians who treat people with genital herpes because controlling an outbreak with a single day of treatment has the potential to impact the overall management of recurrent genital herpes."
The research, presented today at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) also showed that Famvir significantly reduced the duration of RGH symptoms including the itching, pain, burning, tingling and tenderness in patients with lesions versus placebo. Based on these findings, Novartis Pharmaceuticals Corporation filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a single-day Famvir treatment indication in the fall of 2005.
"Millions of Americans are living with this condition and trying to cope with the pain and discomfort each outbreak brings," said Alex Gorsky, Chief Executive Officer, Novartis Pharmaceuticals Corporation. "We are responding to those with recurrent genital herpes to bring them a single-day treatment option that can actually prevent their initial symptoms from becoming a full outbreak. This study with single-day Famvir underscores our commitment to continue to make RGH more manageable for Americans living with this condition."
Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1g orally twice; n=163) with placebo (n=166) showed that when patients with RGH initiated therapy with Famvir at the first sign of an outbreak (within six hours), Famvir significantly reduced the time to healing of non-aborted lesions by two days (median time, 4.3 vs. 6.1 days; P < 0.001). Furthermore, the proportion of patients with aborted lesions was significantly larger in the Famvir group (23.3% vs. 12.7%; P=0.003) compared to placebo. Famvir also significantly reduced the duration of all studied symptoms including the itching, pain, burning, tingling and tenderness in patients with lesions vs. placebo (median time, 3.3 vs. 5.4 days; P < 0.001). Adverse event frequency and severity in the Famvir group were infrequent overall, of mild to moderate severity and similar to those in the placebo group.
About Genital Herpes
Genital herpes is one of the most common sexually transmitted diseases in the United States. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90 percent of people affected with genital herpes may not know they are infected. Anyone who is sexually active with an infected partner can get genital herpes, however, typically more women are diagnosed with genital herpes than men.
There is no cure for genital herpes. Oral antiviral medications such as Famvir are indicated to treat or suppress RGH. People with genital herpes can treat it suppressively, taking medication every day, or episodically, taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment.
About the Study
These data were obtained through a multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1g orally twice; n=163) with placebo (n=166). Patients were instructed to initiate therapy within 6 hours of onset of prodromal symptoms and/or genital herpes lesions. Patients were then required to return to the clinic within 24 hours of initiating therapy (day 1) and on days 2 and 3. Patients who continued to have lesions were asked to return for clinic visits on days 4 and 5, and then every other day until all lesions healed, or until day 14. Healing was defined as loss of all crusts and normalization of the skin. Aborted lesions were defined as herpetic lesions not progressing beyond papule stage.
About Famvir
Famvir tablets are indicated for the treatment or suppression of recurrent genital herpes in immunocompetent patients; the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients; and the treatment of acute herpes zoster (shingles).
In clinical trials, the most commonly reported adverse events vs. placebo were headache (zoster: 22.7% vs. 17.8%; episodic: 23.6% vs. 16.4%; suppression: 39.3% vs. 42.9%); nausea (zoster: 12.5% vs. 11.6%; episodic: 10.0% vs. 8.0%); and diarrhea (zoster: 7.7% vs. 4.8%; suppression: 9.0% vs. 9.5%).
The efficacy of Famvir has not been established for initial-episode genital herpes infection, ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster. The safety and efficacy of Famvir for suppressive therapy have not been established beyond one year.
There is no cure for genital herpes. There is no evidence that Famvir can stop the spread of herpes to others.
Famvir, Pregnancy Category B, is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir(R) (penciclovir cream). For more information about Famvir, see the full Prescribing Information at http://www.famvir.com.
Forward-looking Statement
The foregoing release contains forward-looking statements that can be identified by terminology such as "potential," "commitment to continue" or similar expressions, or by express or implied discussions regarding the potential approval of a new indication for Famvir by the FDA or by regulatory authorities in other countries, or regarding potential future sales of Famvir. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Famvir to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the new indication for Famvir discussed above will be approved by the FDA for sale in the U.S., or that it will receive any marketing approvals in any other country. Neither can there be any guarantee that Famvir will reach any particular sales levels. In particular, management's expectations regarding commercialization of Famvir could be affected by, among other things, additional analysis of Famvir clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG -- a world leader in pharmaceuticals and consumer health. In 2004, the Novartis Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Novartis Pharmaceuticals CorporationCONTACT: Maryon Clark of Novartis Pharmaceuticals Corporation,+1-862-778-0312 or +1-201-400-8479, maryon.clark@novartis.com, or JenniferJacob of Cohn & Wolfe for Novartis Pharmaceuticals Corporation, +1-212-798-9825 or +1-646-522-1441, Jennifer_jacob@nyc.cohnwolfe.com