Novartis Pharmaceuticals Corporation Release: Single-Dose Famvir(R) Treatment Found To Accelerate Healing Time Of Cold Sore Outbreaks
SAN FRANCISCO, March 3 /PRNewswire-FirstCall/ -- New data presented today at the American Academy of Dermatology (AAD) annual meeting demonstrated that a single dose of the prescription antiviral Famvir(R) (famciclovir tablets) given to patients with recurrent cold sores at the onset of symptoms (within the first hour) 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. A second study also presented today 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.
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-dose Famvir treatment indication for recurrent herpes labialis (cold sores) in immunocompetent patients and a single-day Famvir treatment indication for immunocompetent patients with recurrent genital herpes in the fall of 2005.
"These results are exciting news for the millions of people who suffer from cold sores or recurrent genital herpes each year. These studies showed that Famvir was an effective treatment option that provides a full course of therapy in a single dose (cold sores) or a single day (recurrent genital herpes) by taking the medication during the first few critical hours of an outbreak when the infection is most active," said Dr. Spotswood Spruance, Professor of Medicine, Division of Infectious Diseases at the University of Utah School of Medicine, and lead investigator in the cold sore study. "The implications of these studies are important to physicians because these results may have the potential to significantly influence the overall management of both cold sores and recurrent genital herpes outbreaks."
When the herpes virus is 'triggered' in the body - whether in the form of cold sores or genital herpes - the virus is most active in the first hours of an outbreak, creating a narrow window of opportunity for treatment. These studies demonstrated that when patients were treated with the oral antiviral Famvir during this critical period of time, it shortened the duration of outbreaks and improved the time to resolution of symptoms associated with cold sore and genital herpes outbreaks. Millions of Americans live with herpes virus infection and the pain and discomfort associated with the outbreaks brought on by the condition.
"We are committed to helping herpes sufferers manage this chronic, recurring condition," said Dr. Kamal Hamed, Senior Clinical Research Physician, Novartis Pharmaceuticals Corporation. "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."
About the Studies
Cold Sores: Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-dose Famvir (1500mg orally once; n=152), or single-day Famvir (750mg orally twice; n=157) with placebo (n=168) showed that when patients with cold sores initiated therapy with Famvir at the first symptom of an outbreak (within the first hour) but before the appearance of lesions, Famvir significantly reduced (P<0.001) the time to healing of primary vesicular lesions by two days (median time, 4.4 and 4.0 days vs. 6.2 days, respectively). There was no significant difference between treatments in the proportion of patients with aborted lesions. The proportion of patients with aborted lesions was no different across the groups studied. The study also showed that single dose Famvir (1500mg orally once; n=227) compared to placebo (n=254) also significantly reduced (P<0.001) time to return to normal skin by two days (median time, 4.5 vs. 7.0 days, respectively) and significantly reduced (P<0.001) time to resolution of pain and tenderness in patients with lesions by one day (median time, 1.7 vs. 2.9 days, respectively). Famvir was shown to be well-tolerated and had a similar safety profile as placebo.
Recurrent Genital Herpes (RGH): Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1000mg orally twice; n=163) with placebo (n=166) showed that when patients with RGH initiated therapy with Famvir at the first symptom/sign of an outbreak (within six hours), Famvir significantly reduced (P<0.001) the time to healing of non-aborted lesions by two days (median time, 4.3 vs. 6.1 days). Furthermore, the proportion of patients with aborted lesions was significantly larger (P=0.003) in the Famvir group as compared to placebo (23.3% vs. 12.7%). Famvir also significantly reduced (P < 0.001) the duration of all studied symptoms consisting of burning, tingling, itching, pain, and tenderness in patients with lesions vs. placebo (median time, 3.3 vs. 5.4 days). Adverse events were of mild to moderate severity, and were similar in frequency and severity to those in the placebo group.
About Cold Sores
Cold sores, medically known as herpes labialis, are an infection of the mouth area with the herpes simplex virus. It is estimated that cold sores affect 66 percent of American adults - with most Americans being infected by the age of 20 years. Annually, approximately 100 million episodes of recurrent cold sores occur in the U.S. Oral antiviral medications can shorten the course of an outbreak and improve the time to resolution of symptoms (pain and tenderness) associated with cold sores, however, there is no cure for cold sores.
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.
Famvir (famciclovir 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.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. 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 offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
The foregoing release contains forward-looking statements that can be identified by terminology such as "have the potential" "committed to helping" 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.Novartis Pharmaceuticals Corporation
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Web site: http://www.famvir.com/