August 3, 2006
In the future, sexual desire — male and female — may be just a sniff away.
So promises Palatin Technologies, a pharmaceutical firm based in Cranbury. The company is developing a drug, packaged as a nasal spray, that looks like a whole new way to boost sagging libidos. The spray, which is undergoing clinical trials and is at least three years from the market, is a synthetic, colorless, odorless and tasteless substance and carries the unwieldy name of Bremelanotide. Pronounce it slowly, or just call it BMT for short.
BMT appears to produce “on-demand” sexual desire, in the words of Palatin CEO and President Carl Spana. A single dose has been shown to spark arousal in as little as 10 to 45 minutes. The side effects so far are mild — headache and nausea — and neither food nor alcohol appears to interfere with it.
Clinical trials have shown BMT to be at least as effective in men with erectile dysfunction as existing medications such as Viagra, Levitra and Cialis, which are classified as PDE-5 inhibitors. It also appears to be effective in men who don’t respond to those drugs.
But it is the nasal spray’s effect on women that really excites both the drug’s maker and sexual health researchers, not to mention Palatin’s shareholders. Landmark studies like the 1994 National Health and Social Life Survey have demonstrated that more women than men experience some form of sexual dysfunction (43 percent to 31 percent). Women also are generally twice as likely as men in their age groups to say they lack interest in sex, according to a 1999 study called “Sexual Dysfunction in the United States.”
And yet no pharmaceutical company has been able to develop and bring to market a medication that boosts women’s libido. Pfizer unsuccessfully tried Viagra on women. Procter & Gamble’s Intrinsa, a testosterone patch shown in studies to increase women’s libido, failed to earn FDA approval.
“There is a market,” Spana said, “but it is not being satisfied.”
Bremelanotide could be the magic bullet, or the magic spritz, if you will.
About 1,500 men with erectile dysfunction, 200 “normal” men and 50 women have undergone trials of the drug. While confidentiality agreements make it impossible to speak with them, bits of anonymous commentary posted on the Palatin Web site trumpet the nasal spray the way critics might praise a film. “On the five point scale,” Patient 41 is quoted as saying, “I’d score the erection I had as a six.”
And so it is to men that BMT will first be marketed, once clinical trials are completed and the drug wins approval from the Food and Drug Administration. (Spana of Palatin anticipates that to be anywhere from mid-2009 to early 2010.)
And, in a recent small-scale study of the drug’s effect on pre-menopausal women with sexual arousal disorder, the company reported that two-thirds of the participants (12 of 18) experienced some boost in their sex drive after taking BMT and watching 20 minutes of a pornographic movie, preceded by 20 minutes of a non-pornographic one.
The study, published in the July edition of the Journal of Sexual Medicine, also reported that most of the women who had a “sexual encounter” within a day of taking BMT said the sex was as good as, if not better than, before they began experiencing arousal problems. Most also initiated the sex with their partner.
The results were enough to make at least one of the study’s authors feel “cautiously optimistic” about BMT’s potential. “This is a drug that will potentially help women do what they want to do,” said Dr. Michael Perelman, co-director of the Human Sexuality Program at New York Presbyterian Hospital. He is also a member of Palatin’s scientific advisory board and a paid consultant who has worked on the clinical trials for both men and women.
The big test will be if and when the FDA approves a large-scale, at-home drug study. If BMT performs well under these conditions, expect to hear celebrations.
Not everyone, however, is thrilled. One of the main reasons it has taken so long to develop a drug for women’s libido is that women’s sexual function is much more complicated than men’s. Men who experience erectile dysfunction often can be treated by simply increasing the blood flow to their penis, which is what PDE-5 inhibitors do. For women, common complaints such as lack of desire and arousal do not appear to be as strongly related to organic causes, like cardiovascular functioning.
Instead, a woman’s “lack of desire seems to be very much associated with the quality of relationship she is in,” said Professor Edward Laumann, chair of the University of Chicago’s sociology department and the lead author of the National Health and Social Life Survey. Deep relationship problems can deaden desire, and there is a concern that troubled couples may not be able to resolve their differences if they have a way to artificially stimulate their sex drives.
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“You haven’t fixed the problem by having her inhale something,” Laumann said.
Stress and a loss of income also contribute to a lack of desire, Laumann said. Women in their 20s with children, he said, were shown to be two to three times more likely to experience a lack of sexual desire than women their age without children. Why is that? “It doesn’t take a rocket scientist to figure out that they are physically exhausted,” Laumann said with a laugh.
“In some ways,” he continued, “it is an adaptive device.” Pregnancy takes an enormous toll on a woman’s body, and if she is in a stressful or unstable situation, perhaps a lack of desire is her body’s way of protecting her from an unwanted pregnancy. “So to call it a sexual dysfunction is somewhat misleading,” Laumann said.
There are also those who argue that the concept of female sexual dysfunction is more than misleading, that it is somewhat of a myth, a “medicalization” of conditions that are either innately social or a matter of natural aging.
Leonore Tiefer, a clinical associate professor of psychiatry at New York University, is one of the most outspoken critics of mass marketing of sexual medicine. “Sex is something that is supposed to be a joy,” she recently said by telephone, “but what’s happened is that it’s being promoted as a job.”
In a recent essay, Tiefer described the promotion of the idea of female sexual dysfunction as a form of “disease mongering.” She argued that during the late 1990s, urologists and pharmaceutical companies took to amplifying reports of sexual dysfunction in women and used that as a fuel to create a demand for something like a “female Viagra.”
What concerns Tiefer is not so much the money that people spend on sex meds, which currently cost $9 to $10 a dose, but the way drugs impact people’s expectations about their sex lives. While it is perfectly normal for sexual aptitude to drop off with age, she says, medications make people think they should be “highly functional from age 16 to death.”
Certainly there is reason to be concerned that market interests are driving pharmaceutical companies to promote sexual dysfunction as a medically curable condition. One recent study pegged the value of the sexual pharmaceutical market at $3.8 billion, and estimated that it will rise to $6.6 billion by 2012.
Consumers are also expected to pay more for these drugs down the road. Spana of Palatin Technologies says he expects costs to rise to $11 to $12 per dose by the time BMT hits the market. He said BMT would be priced comparably.
High costs are one of the chief reasons he dismisses the notion that female sexual dysfunction is somehow made up.
“It is extremely expensive if you are trying to build a false disease,” he said. He placed the total anticipated cost of developing BMT at around $170 million.
Plus, he said, “My gut tells me this is a legitimate problem. When you have a failure to perform sexually, it is a very in-your-face message.” In many cases, losing sexual function is the first sign that a person is over the hill. A medication can help at least ease the tumble.
“Are we saving someone’s life? Certainly not,” Spana said. But “when you do it right, these patients say, ‘I feel more normal now.’”
For others who support research into Bremelanotide, the question boils down to a matter of free choice and equal opportunity.
“If this is an experience that a woman wants to have, I believe in her physician’s right to prescribe a drug that might assist that,” said Perelman, a member of Palatin’s scientific advisory board. “I believe that women deserve the same opportunity as men.”
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