Drug to remove women's inhibition about sex.

Legalized spanish fly ?


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Desire Drug May Prove Sex Really Is All in Her Head (Update1)


Nov. 13 (Bloomberg) -- Boehringer Ingelheim GmbH is banking on sex really being all in women’s heads.

The German drugmaker is putting the finishing touches on a pill designed to reawaken desire by blunting female inhibitions. Unlike Viagra, which targets the mechanics of sex by boosting blood flow to the penis, this drug works on the brain.

The desire drug, the focus of a meeting on sexual disorders in Lyon next week, has the potential to revolutionize sexual medicine much as Pfizer Inc.’s blue pill did a decade ago. That could put family-owned Boehringer at the center of a debate about whether the medicine is a chemical shortcut around a complex dysfunction involving body and mind -- or whether disinterest in sex is a legitimate medical condition.

“This drug has the potential to finally open the door to acceptance of the idea that decreased desire can be something that involves a dysfunctional way the brain works, and not only a bad partner,” said Jim Pfaus, a neurologist at Concordia University in Montreal, who conducted early tests of the drug in rats. “Of course it’s in your head.”

The U.S. market for medicines to rekindle female libido could be bigger than the $2 billion a year in U.S. sales for erectile dysfunction treatments because more women report sexual problems, BioSante Pharmaceuticals Inc. Chief Executive Officer Stephen Simes estimated last year.

Showing It Works

Boehringer, based in the German town of Ingelheim on the Rhine’s west bank, was searching for a depression treatment in the 1990s when it stumbled on the compound, called flibanserin. By 2002, Boehringer found the drug wasn’t lifting patients’ mood. The company says researchers were startled when test subjects rated one measure of well-being, sexual appetite, consistently higher than the others.

After what Pfaus described as an initial period of hesitation about developing a sex pill, Boehringer decided to move forward. The company needs new drugs because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection next year.

The world’s largest closely held pharmaceutical company has been studying flibanserin for more than a decade and it has yet to publish clinical test results showing the drug is effective. The company will lift its veil of secrecy on Monday at the European Society for Sexual Medicine conference with data from trials of more than 5,000 European and U.S. women.

Women’s Distress

The main criterion for the clinical trials, which the company named after flowers, was how many “satisfying sexual events” women said they had experienced after starting treatment. If the results are good, the so-called Bouquet studies, dubbed Violet, Daisy, Dahlia and Orchid, could form the basis for applications to U.S. and European regulators.

The German company is taking a page from Pfizer’s book. The U.S. drugmaker broadened the appeal of Viagra in 1998 by steering clear of the word “impotence” and saying the blue pill addressed a disease called erectile dysfunction. Boehringer is avoiding potentially offensive words such as frigidity and refers to the problem its pill cures by its clinical name, hypoactive sexual desire disorder, or HSDD.

“An increasing body of evidence shows that hypoactive sexual desire disorder causes substantial emotional distress,” said Heike Specht, a spokesman for the company. The drugmaker “has conducted late-stage clinical trials in over 5,000 women from which we hope will result the first available pharmaceutical treatment.”

A Boehringer survey of 31,000 U.S. women aged 18 and above found that one in 10 expressed distress because of diminished sex drive.

Ideological Battle

A sluggish libido is “a real problem,” and early clinical results so far suggest Boehringer’s drug can help, according to Stephen Stahl, a psychopharmacologist and chairman of the Neuroscience Education Institute in Carlsbad, California. Stahl, who has been a consultant for Boehringer, sees a growing role for drugs in treating sexual disorders.

Not everyone agrees there is a disorder to begin with.

In 2003, a year after Boehringer started the Bouquet clinical trials, an article written by Ray Moynihan in the British Medical Journal called female sexual dysfunction “the freshest, clearest example we have” of a disease created by pharmaceutical companies to make healthy people think they need medicine.

“This is for some an ideological battle,” said psychiatrist Michael Berner of the Freiburg University Clinic, who had patients in Boehringer’s studies. “One view is the multi-dimensional view you get from people like me. And then you have these people that say you should work only on relationship issues and that medication cannot have a place.”

‘Like Dancing’

Researchers don’t know why some women’s libido falters, said Pfaus, who has tested compounds in rats for Pfizer, Boehringer and Palatin Technologies Inc. by gauging whether they spur female rats to solicit sex from males.

“An erection is obvious, it’s easy,” Pfaus said. “But desire -- how do you get at that?”

The explanation may be partly evolutionary, according to Berner, who says male primates are driven by a need to spread their semen, while for females it’s important to be able to care for and rear the offspring.

Some researchers believe the social components of intercourse mean that sexual problems can’t be addressed in the same way as heart failure or cancer.

Sex is a “historical and cultural phenomenon,” said Leonore Tiefer, a psychiatry professor at New York University. There’s no baseline of normalcy by which to define a disorder, she contends.

“It’s like dancing, or music, or piano-playing,” Tiefer said. “You do it with the body, but the part the body plays isn’t the largest part.”

Over the Wall

Flibanserin works on the brain by putting “two feet on the brakes” to block the release of a chemical called serotonin, which regulates mood, appetite, sleep and memory, Pfaus said. In time, the process should trigger the production of dopamine, a chemical that, among other jobs, helps stimulate desire.

The drug differs from testosterone, a hormone that’s also been tested to reawaken women’s desire. Berner, interviewed at his study in Freiburg, sketched the picture of a wall to explain how flibanserin works.

“You’re standing here, sad, inhibited,” he said, drawing a stick figure next to the wall on a scrap of paper. “Testosterone would give you a little bit more excitement, so you’d climb over. Flibanserin would take away one of the stones.”

Once a Day

The compound takes three to six weeks to kick in. The pill has to be taken daily, and some women taking part in the clinical trials reported feeling tired, Berner said.

Boehringer recruited women for clinical studies using print advertisements. Berner said his patients were largely professionals in their early 30s to mid-40s, and most chose to continue in the trial in a subsequent phase that ensured they would get the real drug instead of a placebo. Boehringer is recruiting older women for a follow-up study.

Women can be diagnosed with hypoactive sexual desire disorder if they feel concerned, bothered or frustrated by a lack of desire -- or if it’s hurting their relationships.

The company used personal digital assistants to check whether the pill was working. Participants were beeped once a day and asked to rate their level of desire and say whether they had been sexually active and whether it was enjoyable.

Potential Rivals

If flibanserin makes it to market, it will be the first success after a series of failures from drugmakers including Procter & Gamble Co. and Pfizer. The New York-based maker of Viagra abandoned efforts to adapt its pill for women in 2004 and closed sex-health research at the end of last year.

The only female sexual dysfunction therapy approved in the U.S. is Eros-CTD, from NuGyn, Inc., a suction pump that fits over the clitoris much like the erection pumps that predated Viagra. Intrinsa, a testosterone patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is sold in Europe for women whose uteruses have been removed. A U.S. version was put on hold in 2004 on concern about whether it is safe for long-term use.

Still in clinical trials are a new version of the P&G patch; LibiGel, a testosterone gel from BioSante; and bremelanotide, an injected therapy from Palatin Technologies.

Researchers around the world will be watching Boehringer’s results in Lyon, according to Pfaus. “There are probably a lot of companies holding their breath,” he said.