Placebo Is The Real 'Female Viagra'

Matthew Herper
Placebo Is The Real 'Female Viagra'
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Another day, another biotechnology company whose long, slow path toward patients has ended in failure.

Except this time it's BioSante Pharmaceuticals and its experimental product LibiGel (short for libido, one imagines), a treatment for "hypoactive sexual desire disorder in postmenopausal women." In short, an attempt at creating "Viagra for women."

That, it turns out, is a pretty tough drug project to crack. While, for some men, problems in sexual arousal are basically hydraulic and can be fixed by blocking a chemical called phosphodiesterase-5, causing the penis to fill with blood, low levels of desire in women are a far more complicated matter. Pfizer did try Viagra in women -- it just didn't do much. BioSante's approach was to use a testosterone gel -- an approach that Procter & Gamble had tried only to run into safety worries that led the Food and Drug Administration to not approve the drug.

Women in the clinical trials for LibiGel, which were just announced, did have pretty substantial increases in levels of sexual arousal. The problem for BioSante is that the women in the placebo groups seemed to do almost as well as those who got the drug!

Check out the results, from BioSante's press release:

Subjects in the first trial, called BLOOM-1, who were treated with LibiGel showed an increase of 1.47 days with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline. The difference between these increases demonstrated a p value of 0.463. In BLOOM 1 there was an increase in the total number of satisfying sexual events of 3.87 from baseline (an increase of 83 percent) in the LibiGel group and in the placebo group there was an increase of 3.52 satisfying sexual events from baseline (an increase of 65 percent) for a p value of 0.698.

Subjects in BLOOM-2 who were treated with LibiGel showed an increase of 1.0 day with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.28 days with a satisfying sexual event compared to baseline. The difference between these increases demonstrated a p value of 0.214.

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. In BioSante's press release, chief executive Stephen Simes says his company is "committed to determining the future of LibiGel." He probably has already done that -- LibiGel doesn't look like it has much of a future. On the other hand, placebo (or time, or giving women with low sex drives encouragement) might be promising, and it certainly seems as if it would merit further study.

Shares in Biosante plummeted 78% to less than $0.50 in after-hours trading.