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| |  One In Five Patients With Cold Sores Gets Relief With Denavir PITTSBURGH, PA -- February 1, 2000 -- Ask any cold sore sufferer and they likely will tell you that the worst things about getting cold sores are that they are so noticeable -- and they can hurt. They are a source of dread because, as every sufferer knows, cold sores get worse before they get better. But a study just published in the peer-reviewed medical journal Clinical Therapeutics offers some promising news for the one-in-five Americans who suffer from recurrent cold sores. Cold sore sufferers treated with penciclovir cream 1%, known commercially as Denavir(R), saw approximately a 30 percent reduction in the average maximum cold sore size compared with patients who were treated with placebo only, according to the study. Study participants who used Denavir also reported that pain and other symptoms associated with cold sores, such as burning, itching, tingling and tenderness, were reduced significantly throughout the course of treatment. In addition, as early as Day three of treatment, patients treated with Denavir were nearly 20 percent less likely than those treated with placebo to report that the overall severity of their cold sores was moderate to extreme. "Essentially, patients who were treated with Denavir reported significant benefits compared to those who were treated with the placebo only," said J. John Goodman, M.D., a lead investigator of the study, and a former clinical professor of dermatology at the University of Miami School of Medicine. "Denavir not only made the cold sores heal better, it made the cold sore sufferers feel better, since the sores were less noticeable and irritating." While the results of a 1997 study established that Denavir helped cold sores heal on average in 4.5 days, this new clinical study demonstrates that the medicine yields tremendous additional therapeutic benefits, including: -- A reduction in the average maximum cold sore size by approximately 30 percent, as compared with those treated with placebo only; In addition, the therapeutic effects of Denavir were clearly apparent to both investigators and patients, neither of whom was aware of whether they were in the treatment or placebo group. The study investigators assessed efficacy as highly effective/effective in 63.5 percent of patients treated with Denavir compared with only 34.5 percent of patients treated with placebo. Similarly, 67.7 percent of patients treated with Denavir rated their medication as a highly effective/effective treatment for cold sores compared with only 34.2 percent of the patients treated with placebo. "Despite the challenges of proving antiviral efficacy in recurrent herpes labialis [cold sores], penciclovir cream has been shown to provide relief to cold sore sufferers throughout the course of an episode for a broad range of clinically important outcomes," said the report in Clinical Therapeutics. "The significant effects on lesion area, lesion symptoms and other lesion attributes extend the therapeutic ability of penciclovir cream in the treatment of herpes labialis beyond lesion healing." To fully determine the medical benefits of penciclovir cream 1%, the maker of Denavir, SmithKline Beecham, commissioned the first clinical study that has ever looked specifically at the medicine's effects on cold sore symptoms, such as cold sore size, severity and noticeability. The study was conducted at 12 centers in the United States, with different clinical investigators overseeing tests at each facility. All subjects took a placebo tablet three times a day so that patients treated with water would believe they were receiving active treatment, thereby discouraging additional use of a topical agent. Patients chosen for the test were males and females aged 18 or older, with a history of sun-induced cold sores that recurred at least three times a year. The study population was predominantly female (75 percent) and Caucasian (92 percent) with a median age of 38. Ron Boon, SmithKline Beecham's worldwide clinical director for Denavir, praised the study for its scope and scholarship. "This clinical study proves beyond a doubt that Denavir is a very effective cold sore treatment," Boon said. An estimated 40 million American adults suffer from recurrent cold sores, which are caused by a virus. Cold sore sufferers generally experience anywhere from two to 12 occurrences a year. The cold sore virus lies dormant, or asleep, inside a nerve in the upper jaw until it is triggered and results in a visible cold sore. Stress, sunlight, extreme weather temperatures and colds and flus are among common cold sore triggers. According to a Gallup Poll conducted by SmithKline Beecham, cold sores are a major disruptive force in sufferers' lives. According to the poll: Those who have missed work call off sick an average of four days a year. That's 6.4 million missed work days each year. Denavir is the first and only prescription medicine approved by the U.S. Food and Drug Administration for the treatment of recurrent cold sores in healthy adults. It is a tasteless and odorless topical cream that dries invisibly when applied to the affected areas. Antiviral Denavir penetrates the skin to block the virus that causes cold sores. Current over-the-counter products used by cold sore sufferers do not treat the viral cause of cold sores and only provide temporary relief of some of the symptoms; prescription Denavir blocks the viral cause and relieves the symptoms of cold sores. Related Links: Denavir (penciclovir cream 1%) and SmithKline Beecham.
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