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| |  FDA Approves Supplemental New Drug Application for Antiviral Treatment Famvir(R) (Famciclovir) Famvir approved to treat recurrent genital herpes outbreaks with single day of therapy Famvir approved to treat cold sores with single dose of therapy EAST HANOVER, NJ -- July 31, 2006 -- Novartis Pharmaceuticals Corporation announced today the U.S. Food and Drug Administration (FDA) approved prescription Famvir® (famciclovir) tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application (sNDA). Famvir significantly reduced the time to healing of non-aborted lesions, as well as time to resolution of studied symptoms in RGH patients with lesions by almost two days. The FDA also approved Famvir as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients. "Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day," said Gregory Geba, MD MPH, Vice President and Therapeutic Area Head of Respiratory, Dermatology and Infectious Diseases, Novartis Pharmaceuticals Corporation. "The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients." When an outbreak is triggered in the body, there is a narrow window of opportunity for treatment since the virus is replicating most actively in the first hours of an outbreak. Data shows 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. Millions of Americans live with the pain and discomfort associated with the outbreaks brought on by these conditions. The new approved dosage of Famvir for RGH is 1,000 mg twice daily for one day. Therapy should be initiated within six hours of the first sign of prodromal symptoms, such as tingling, itching, burning or lesion appearance. Ninety-one percent of patients can identify their prodrome allowing them to initiate therapy in this narrow window of opportunity. Similarly, the cold sore virus is most active during the first hours of an outbreak. Data shows that when a single 1,500 mg dose of Famvir therapy is initiated within one hour of the first sign of symptoms (tingling, itching or burning) of a cold sore, Famvir significantly reduced the time to healing by a median of almost two days, as well as the time to resolution of pain and tenderness by a median of one day. "This is exciting news for the millions of people who live with these conditions," said Dr. Geba. "Treating at the first sign of symptoms, when the virus is generally most active, significantly influences the management of outbreaks." About the Data 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. Cold Sores: Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-dose Famvir (1,500 mg orally once; n=152), or single-day Famvir (750 mg orally twice; n=152) with placebo (n=168) showed that when immunocompetent adult 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 almost 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 study also showed that single dose Famvir (1500mg orally once; n=227) compared to placebo (n=254) also significantly reduced (P<0.001) the time to resolution of pain and tenderness in patients with lesions by one day (median time, 1.7 vs. 2.9 days, respectively). Adverse events were mild to moderate severity and were similar in frequency and severity to those in the placebo group. About Genital Herpes There is no cure for genital herpes. Oral antiviral medications such as Famvir are indicated to treat or suppress RGH. People with recurrent genital herpes can treat it suppressively, by taking medication every day, or episodically, by taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment. About Cold Sores About Famvir In clinical trials, the most commonly reported adverse events vs. placebo were headache (zoster: 22.7% vs. 17.8%; episodic: 13.5% vs. 5.4%; suppression: 39.3% vs. 42.9%; cold sores: 9.7% vs. 6.7%); nausea (zoster: 12.5% vs. 11.6%; episodic: 2.5% vs. 3.6%; suppression: 7.2% vs. 9.5%; cold sores: 2.2% vs. 3.9%); and diarrhea (zoster: 7.7% vs. 4.8%; episodic: 4.9% vs. 1.2%; suppression: 9.0% vs. 9.5%; cold sores: 1.8% vs. 0.8%). 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 has 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 is Pregnancy Category B. Famvir is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir® (penciclovir cream).
SOURCE: Novartis Pharmaceuticals Corporation
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