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FDA Approves Non-Prescription Cold Sore Topical Treatment Docosonal 10% SAN DIEGO, CA -- July 26, 2000 -- Avanir Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted full marketing approval for docosanol 10% cream, a topical treatment for recurrent oral-facial herpes simplex infections, commonly known as cold sores or fever blisters. The first drug product of Avanir Pharmaceuticals, docosanol 10% cream is also the first FDA approved product for the treatment of cold sores able to be sold without prescription. "Today's approval is a demonstration of the dedication, experience and quality of our staff and consultants, who were able to work successfully with the FDA to ultimately achieve approval of the product," said Gerald J. Yakatan, Ph.D., president and CEO of Avanir. "It gives me great confidence in our ability to move future products through the pipeline and into the market. This is a significant achievement and we are elated to have accomplished this goal." "Docosanol 10% cream has a novel mechanism of action and is most effective early in the course of an outbreak. As a result, docosanol 10% cream reduces the length of time patients experience discomfort from cold sores," said Stephen Sacks, M.D., a leading clinician and scientist in the field of antiviral therapy and founder and president of Viridae Clinical Sciences, Inc. "This product will provide an important new topical treatment option for my patients." Eighty percent of adults in the United States are carriers of the virus that causes cold sores. Each year, 20 to 40 percent of these -- more than 50 million adults -- develop symptomatic episodes, characterized by the formation of a blister on the upper or lower lip. The number of treatable episodes ranges from 100 to 130 million outbreaks annually, with 70 to 80 percent of these episodes treated by products in the over-the-counter (OTC) market. In clinical trials, docosanol 10% cream significantly reduced the healing time of patients' cold sore episodes compared to placebo (p<0.01). In addition, patients treated with docosanol demonstrated statistically significant reductions in the duration of associated symptoms of pain and/or burning, itching or tingling when compared to placebo (p<0.01). Cold sore episodes can be brought on by a variety of factors, including stress, fever, fatigue and exposure to sunlight. Cold sore sufferers have reported that they avoid family and friends during outbreaks, which usually last about a week, but can last as long as two weeks. Up to 15 percent of sufferers have reported staying home from work during an outbreak. Due in part to the fact that there have been few effective treatments, only a small percentage of patients seek professional care. "Cold sores have a negative impact on the lives of millions of Americans, but most people believe there isn't anything that can be done to effectively treat outbreaks," said Terry M. Jones, M.D., an investigator in the company's clinical trials. "Docosanol 10% cream can make cold sore sufferers more comfortable both physically and psychologically and able to return to their normal activities sooner." Related Link: Avanir Pharmaceuticals. E-mail this page to a friend or colleague! To print, use this version