Cancer therapies should shrink tumors. Diabetes treatments ought to lower blood sugar. But what should society expect from drugs for sexual desire?
In the coming days, the Food and Drug Administration will decide whether to approve an injection meant to increase women’s drive for sex. Its demonstrated effects are modest, but some doctors say the drug would meet a real need for thousands of women. Others, however, argue it is simply pharmaceutical overreach, another effort that reduces the complexity of human sexuality to a set of measurable dots on a chart.
“It’s a mismatch of models,” said Leonore Tiefer, a sex therapist who previously ran the sex and gender clinic at New York’s Montefiore Medical Center. “They want the car repair model: ‘Hello, doctor, I’ve got this carburetor that doesn’t work in my car. Could you fix it for me without talking to me?’ It’s laughable.”
The drug, bremelanotide, is an on-demand therapy for women with hypoactive sexual desire disorder, or HSDD, which is defined as a distressing loss of interest in sex. And its Massachusetts-based manufacturer, AMAG Pharmaceuticals (AMAG), hopes the drug can do for sexual desire what Viagra did for erectile dysfunction. It could win FDA approval as early as Friday.
There’s already a marketed treatment for HSDD in the form of a pill called Addyi, a drug whose 2015 FDA approval came with intense debate over whether sexual desire was indeed a medical issue. Addyi has since become a commercial nonentity, in large part because women are restricted from drinking alcohol before taking it. The controversy around the drug’s approval faded along with its meager sales.
But bremelanotide, which promises a similar effect with fewer side effects, has rekindled the conversation around whether sexual desire can be a matter of pharmaceutical science.
Dr. Sharon Parish, who practices sexual medicine at NewYork-Presbyterian Hospital, said the debate over HSDD is “an old argument that there’s no point in having anymore.” Regardless of the semiotics of female sexuality, there are women in the real world suffering distress from a lack of desire, Parish said. To deny them drugs that might help is to ignore their lived experience and minimize their pain, she said.
“Lighting a candle and having a glass of wine isn’t helpful for these women, just as going to see a funny movie isn’t helpful for someone who’s depressed,” said Parish, who has served as a paid adviser to AMAG.
Skeptics of drugs like Addyi and bremelanotide argue that they’re not dismissing the distress that comes with conditions like HSDD; they’re taking it seriously by acknowledging the nuances of human sexuality.
To Emily Nagoski, a sex educator and author, prescribing drugs for desire runs the risk of pathologizing normal sexual function. What women diagnosed with HSDD need “is not medical treatment, but a thoughtful exploration of what creates desire between them and their partners,” Nagoski wrote in the New York Times before Addyi’s approval.
To Tiefer, sexuality is best understood through what she calls the dancing model. Dancing, like sex, requires a having body, but no one would study the art of ballet by cracking open Gray’s Anatomy. So why, Tiefer asks, would anyone isolate the biology of sex at the expense of its other facets?
“Sex is a construct,” Tiefer said. “There’s a body — a penis, a vagina, a circulatory system. And then there’s relationships, people, marriage. But there’s really no such thing as ‘sex.’”
AMAG’s approach to the biology of sex begins in the brain. Desire, the company argues, is governed by a compromise between excitatory and inhibitory neurons. Women with HSDD are imbalanced toward inhibition. Bremelanotide, which targets an excitatory receptor called melanocortin 4, is meant to even things out, improving desire and reducing distress.
The drug, self-administered through a tiny needle that goes under the skin, met its goals in a pair of clinical trials involving more than 1,200 women. At the median, bremelanotide decreased distress by one point from baseline on a four-point scale. The results in desire were smaller, with the median patient seeing an improvement of just .6 from baseline on a scale that ranges from 1.2 to 6.
AMAG, which licensed bremelanotide from Palatin Technologies in 2017, argues that such an improvement is enough to spell a real benefit for women with HSDD. The scale comes from a questionnaire that asks women how often and how intensely they want to have sex. AMAG’s goal was never to maximize scores, Chief Medical Officer Dr. Julie Krop said, but to move the needle such that each woman might return to her own definition of normalcy.
“We’re not trying to prescribe a one-size-fits-all desire,” Krop said. “It’s about empowering women to have the choice and the ability to restore their desire where they think it’s been robbed.”
The distress of HSDD can overburden relationships and spill over into the workplace, said Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Cleveland Medical Center. Even a seemingly marginal benefit can have outsized impacts on women’s quality of life, she said.
“While it may look sort of modest to a statistician or to a layperson, it is meaningful to my patients,” said Kingsberg, who has led studies of bremelanotide and served as a paid adviser to AMAG.
But finding the women who might benefit from bremelanotide will likely be a challenge, AMAG acknowledges.
HSDD is a diagnosis of exclusion. A woman must perceive her sexual desire to have diminished, and she must consider that change to be distressing. But for her condition to be HSDD, a doctor must rule out every other possible cause of her waning sex drive, whether it be a relationship problem, the side effects of another medicine, or the lasting impact of a surgery.
That’s largely why Wall Street has taken a dim view of bremelanotide’s commercial future.
Addyi’s failure looms in the minds of investors. That drug, marketed by Sprout Therapeutics, has seen its sales fall by more than 90% since its 2015 approval, according to the drug industry research firm IQVIA.
Addyi’s biggest barrier to success was an FDA-imposed restriction on women drinking alcohol before taking the drug, according to analysts. Bremelanotide shouldn’t have that issue, according to SVB Leerink analyst Ami Fadia, but it’s still unlikely to bring in outsized revenue for AMAG.
Women might balk at the idea of reaching for an injector pen before sex, Fadia said. And while there are roughly 5 million women in the U.S. who could be candidates for bremelanotide, “the more difficult question to answer is what percentage of those women are really seeking treatment,” she said. “That’s where the numbers can start to get very small.”
Krop, AMAG’s head doctor, knows the company has work to do when it comes to educating women and their doctors about HSDD. The company built a website called UnBlush.com that serves as “a place for women to speak up and get answers about low sexual desire that frustrates us,” according to its homepage. Included are video testimonials, animated GIFs, and a quiz promising to tell women whether they have the symptoms of HSDD.
Kingsberg, who practices clinical psychology, said she hopes the future of female sexual dysfunction mirrors the recent history of depression. Doctors once looked at depression as a psychosomatic disorder, outside the reach of medicine. The advent of drugs like Prozac gave them something to prescribe, Kingsberg said, transforming diagnosis and treatment in the process.
“HSDD is exactly the same,” she said. “Women suffer in silence not knowing that it’s a condition that is real — and that is treatable.”