An over-the-counter topical cold sore medication has been approved by the U.S. Food and Drug Administration for the first time.
Docosanol 10 percent topical cream (Avanir Pharmaceuticals) treats recurrent cold sores on the mouth and face that are caused by a herpes simplex virus. It is the first FDA-approved product for the treatment of cold sores able to be sold without a prescription.
In clinical trials, docosanol significantly reduced cold sore healing time compared with an inactive placebo cream. In addition, patients treated with docosanol demonstrated statistically significant reductions in the duration of symptoms—pain, burning, itching and tingling—compared with control patients. The drug is most effective in an infection’s early stages, thereby reducing the cold sore’s duration.
According to Avanir’s press release, 80 percent of adults in the United States are carriers of the herpes simplex virus that causes cold sores. Each year, more than 50 million adults experience symptomatic episodes that are characterized by the formation of a blister on the upper or lower lip and that is brought on by a variety of factors, including stress, fever, fatigue and sunlight exposure.
Avanir has licensed this drug to SmithKlein Beecham to manufacture and market it in the United States and Canada.
