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European regulators are considering whether to approve a condom containing a gel that helps men maintain a firmer erection. Developed by Futura Medical PLC, a UK-based biotechnology firm, CSD500 is noteworthy in a market where innovation is rare and patent protections are uncommon. The gel in CSD500 is absorbed by the skin, boosting blood flow and enhancing erection. It is based on a generic compound for the treatment of angina, severe chest pain caused by lack of blood flow to the heart. The hurdle for Futura was immobilizing the gel so that the vasodilator maintains its integrity and only makes contact with the wearer during intercourse.
"Some products can degrade the latex very quickly," explained Futura CEO James Barder. "The challenge is having a stable product in a condom, a gel that doesn't do anything detrimental to the condom." Most of the patents involving CSD500 center on this immobilization, he said.
Though considered "Viagra for condoms," CSD500 is not classified as an erectile dysfunction treatment. Instead, it targets men who struggle to maintain an erection while wearing a condom. Designation as a medical device, rather than a drug, means CSD500 would be sold over-the-counter. The hope is that CSD500 will encourage men to use protection, thus helping prevent the spread of STDs.
Regulators in Europe are expected to rule on CSD500 during the first half of 2011, meaning the condom could be on pharmacy and supermarket shelves by year's end. If marketers decide to seek US approval, the Food and Drug Administration would require additional clinical data from US patients, said Matrix Group analyst Navid Malik.
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