Placebo effect undermines crucial clinical trial for LibiGel

The power of suggestion and anticipation can be just as potent as a drug it seems, especially when it comes to sex. Or at least that’s one of the conclusions that could be reached in the aftermath of phase 3 clinical trials testing the efficacy of LibiGel, which is designed to treat sexual dysfunction in postmenopausal women.

In the six-month-long tests involving more than 1,000 women, the women who received LibiGel showed a similar number of satisfying sexual events compared with the women who received the placebo. As Stephen M. Simes, BioSante’s (NASDAQ:BPAX) CEO, said in a conference call following the announcement of the results:

“The problem isn’t that LibiGel did not work. … It’s that the placebo did just as well.”

LibiGel was developed by Antares (AMEX:AIS) and BioSante. As BioSante directors scratch their heads and try to figure out how to proceed, the reaction to the news was varied.

Matthew Herper, who covers the pharmaceutical industry for Forbes, wrote:

For all intents and purposes, the placebo was just as good as the drug! This may be because women who enter a clinical trial for female sexual dysfunction are already at a low point, and they’re bound to improve. Or it may be that getting treatment affects their state of mind and increases their libido. Either way, the message is that these women did improve — it got better. But that didn’t seem to require LibiGel.

Bloomberg’s Michelle Fay Cortez observed that female sexual dysfunction has been a particularly challenging market to break:

Boehringer Ingelheim GmbH abandoned development of its female desire pill flibanserin in October after U.S. regulators said it wasn’t proven safe and effective. Pfizer Inc. stopped developing Viagra, its blockbuster male impotence pill, for women in 2004. Procter & Gamble Co. failed to win marketing approval of a testosterone patch the same year.

Even before the results were published Seeking Alpha analyst Larry Smith pointed out it’s not exactly accurate to compare LibiGel to Viagra for women.

Viagra and its competitors treat a distinct physiological condition in which the male is unable to obtain an erection. This can usually be corrected by increasing blood flow to the penis, which is what Viagra does. Female sexual dysfunction is more complex and results from the interplay of a number of physical and psychological disorders. HSDD is probably the most common cause of female sexual dysfunction, but there are other prominent causes.

The placebo effect is getting increased attention in understanding how bodies heal.Ted Kaptchuk, who heads up Harvard University’s Program in Placebo Studies, received funding from the National Institutes of Health to investigate the placebo effect and develop a deeper understanding of what causes it.

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