New Condom Nears Approval

By TOMMY STUBBINGTON

LONDON—A new erection-enhancing condom product, dubbed "Viagra for condoms," is nearing regulatory approval and could be on sale in Europe by the end of the year.

Analysts say the condoms, which contain a gel that helps men maintain a firmer erection for longer, could make a significant splash in the condom market, where innovation is rare and patent-protected inventions are hard to come by.

The product could also provide a boost to Durex, the world's biggest-selling condom brand, not least in the U.S., the world's largest market and one where Durex has struggled to gain a sizable market share.

European regulatory approval for the product, developed by U.K. biotechnology firm Futura Medical PLC and licensed to Durex's owner SSL International, was held up during SSL's takeover last year by consumer goods giant Reckitt Benckiser Group PLC. Futura now expects the green light in the first half of 2011, meaning the condom, named CSD500, could be on the shelves of pharmacies and supermarkets by the end of the year.

Disappointing end to an important study shows PrEP may not work in women

In the latest twist on the biomedical prevention roller-coaster, a trial testing Pre-Exposure Prophylaxis (PrEP) in women has ended early because it failed to show positive results. That is bad news. It is also surprising news given the same intervention seems to have worked with men who have sex with men. Why the FEM-PrEP Project did not show positive outcomes is not yet known. Adherence to the drug seems to have been high, but we do not yet know how adherence was measured. Too many biomedical prevention trials have relied on self-report adherence, making negative results difficult to interpret. It is also possible that the different HIV transmission dynamics of vaginal and anal intercourse account for the findings. In addition, risk reduction counseling, condoms, and repeated testing that all women received may have reduced the study's statistical power. We will have to wait for more information.

One thing is clear. The behavioral implications of PrEP remain as important as ever. Behavioral and social scientists working in AIDS should pay close attention to what we hear next and consider how 30 years of behavioral research may help move biomedical prevention technologies along. The Press Release is reproduced below.

FHI to Initiate Orderly Closure of FEM-PrEP

April 18, 2011

Following a scheduled interim review of the FEM-PrEP study data, the Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP study will be highly unlikely to be able to demonstrate the effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] in preventing HIV infection in the study population, even if it continued to its originally planned conclusion.