AVANIR Pharmaceuticals Receives FDA Approval for Over-the-Counter Cold Sore Treatment

AVANIR Pharmaceuticals announced 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 that can be sold without a prescription. This approval marks a significant milestone for AVANIR, demonstrating their ability to move future products through the pipeline and into the market.

Key Takeaways:

• AVANIR Pharmaceuticals' docosanol 10% cream is the first over-the-counter (OTC) cold sore treatment to receive FDA approval, providing a novel mechanism of action that reduces the length of time patients experience discomfort from cold sores.
• The product has been shown to significantly reduce healing time of patients' cold sore episodes compared to placebo, with 80% of treated episodes resulting in a 50% or greater reduction in healing time.
• Eighty percent of adults in the United States are carriers of the virus that causes cold sores, with approximately 20 to 40 percent of these carriers developing symptomatic episodes each year, resulting in over 50 million adults experiencing cold sore outbreaks annually.
• Docosanol 10% cream has a unique mode of action, reducing the healing time of patients' cold sore episodes, and is most effective when applied early in the course of an outbreak.
• AVANIR Pharmaceuticals has signed a license agreement with SmithKline Beecham (NYSE: SBH) for the manufacturing and marketing rights to docosanol in the United States and Canada, providing for an upfront licensing payment and milestone payments up to $25 million.
• SmithKline Beecham Customer Healthcare will be responsible for all sales and marketing activities, as well as manufacturing and distribution of the product in the licensed territory, with AVANIR receiving royalties on product sales.

Statistics:

• 80% of adults in the United States are carriers of the virus that causes cold sores.
• 20-40% of these carriers develop symptomatic episodes each year.
• Over 50 million adults experience cold sore outbreaks annually.
• 70-80% of cold sore episodes are treated by products in the over-the-counter (OTC) market.
• Docosanol 10% cream has been shown to significantly reduce healing time of patients' cold sore episodes by 50% or greater.

Sources:

• PR Newswire, "AVANIR Pharmaceuticals Receives FDA Approval for OTC Cold Sore Treatment"
• AVANIR Pharmaceuticals, "AVANIR Pharmaceuticals Receives FDA Approval for OTC Cold Sore Treatment"
• SmithKline Beecham, "SmithKline Beecham Customer Healthcare to Market AVANIR's OTC Cold Sore Treatment"