Another competitor to Lidakol to be very aware of. On first glance it appears to be far superior to acyclovir.
The potential market size for Lidakol is dropping, as the field is getting crowded with potentially superior drugs.
ALBUQUERQUE, N.M., Feb. 10 /PRNewswire/ -- According to a new study,
Famvir(R) (famciclovir, SmithKline Beecham) twice daily is an effective treatment for patients who suffer from frequent genital herpes outbreaks. After four months of treatment, 90 percent of patients who were administered 250 mg of Famvir twice daily were recurrence-free compared to only 48 percent of placebo-treated patients. The study results were published today in
the Archives of Internal Medicine.
"For patients suffering from frequent genital herpes episodes, treatments that completely suppress or significantly reduce the number of recurrent outbreaks are critical. While once a day dosing of an antiviral agent might be more convenient, this study and previous data indicate that you get better suppression efficacy if you dose at least two times a day. More frequent dosing allows the antiviral to continually circulate in the bloodstream, so there's a greater potential to stop the virus in its tracks," said Gregory Mertz, M.D., study author, chief of the division of infectious
diseases and professor of internal medicine at the University of New
Mexico School of Medicine.
The double-blind, placebo-controlled trial that was conducted at eleven universities and nine private ambulatory care referral centers was designed to evaluate the efficacy and safety of Famvir given once or twice daily for the suppression of frequent episodes of genital herpes in women. Female patients (n=375) with recurrent genital herpes simplex infection were randomized to
receive one of five treatment regimens (Famvir 125 mg once or twice daily, 250 mg once or twice daily, or 500 mg once daily) or placebo. Patients were seen monthly during treatment and one month after completion of therapy. At the end of 120 days of treatment, 90 percent of patients treated with Famvir 250 mg twice daily were free fro m virologically confirmed recurrences of genital herpes. Only 48 percent of patients receiving placebo were recurrence-free.
"Famvir is characterized by a high rate of absorption. This is a potential treatment advantage because more of the drug's active ingredient is absorbed into the bloodstream," said Dr. Mertz. Famvir has a bioavailability of 77 percent, compared to 15 percent for acyclovir. The incidence of genital herpes, a contagious and recurrent
viral infection caused by the herpes simplex virus (HSV), is increasing globally. In the United States, 55 million adults have genital herpes with 500,000 new cases of genital herpes occurring annually. It is estimated that up to 80 percent of patients experience subsequent outbreaks of genital herpes. Many patients with genital herpes experience an average of four recurrences
per year. Patients who experience severe and more frequent outbreaks may benefit from suppressive therapy (ongoing antiviral treatment) to prevent outbreaks from recurring.
The results of this study support a previously presented
placebo- controlled clinical trial which demonstrated the efficacy of Famvir in suppressing genital herpes. In this twelve-month study, the median time to genital herpes (herpes simplex) recurrence was greater than one year for patients in the Famvir (250 mg twice-daily) groups and only 2.8 months for patients in the placebo group. Based on these and other study results, SmithKline Beecham (NYSE: SBH) has filed a supplemental new drug application (SNDA) with the U.S. Food and Drug Administration (FDA) for a 250 mg twice daily administration of Famvir(R) (famciclovir, SmithKline Beecham) for suppression of genital herpes.
This study was supported by a clinical grant from SmithKline
Beecham Pharmaceuticals. Famvir is currently indicated for the treatment of recurrent genital herpes and acute herpes zoster (shingles) in immunocompetent individuals. This agent is also being studied for treatment of a number of other infections caused by the human herpesvirus in both immunocompetent and immunocompromised individuals. |
