The Future


The Future

Hey ladies, remember to pack your horny pen

Can a new injectable drug called Vyleesi jumpstart a woman’s libido?

It’s an ongoing and stale trope that women don’t want to have sex — they’re too tired from working and taking care of the kids, they’re getting their period, they would rather fall asleep playing solitaire.

Sadly, there is truth to the fact that many women’s libidos deteriorate over time, and until recently, we could only sit back and take the jabs while our relationships suffered. While Viagra has become something of a cultural institution for men since it hit the market in 1998, women haven’t been able to take a libido drug as needed — until now.

That drug is Vyleesi, an FDA-approved drug to treat Hypoactive Sexual Dysfunction Disorder (HSDD). The condition, which according to the American College of Clinical Pharmacy is experienced by one in 10 women and is characterized by a lack of sexual desire along with marked distress.

Vyleesi, which hit the market this month, is central to a decades-old feminist debate surrounding a woman’s desire. (The drug’s name has certainly raised eyebrows: is it a mashup of Vyvanse and Khaleesi, a sexual stimulant suitable for the mother of dragons? When I asked an AMAG spokesperson, she said there was “no story behind the Vyleesi name other than market research.”) Some doctors see it as an important step toward acknowledging and abating HSDD symptoms, which have been shot down and ridiculed for decades as libido medication has become readily available to men.

“What I want is for women to know that HSDD is a real condition, and it is treatable,” said Dr. Sheryl Kingsberg, the chief of the behavioral medicine division at University Hospitals Cleveland Medical Center (Kingsberg has received consulting payments from AMAG Pharmaceuticals and Palatin Technologies, which market and develop Vyleesi respectively). “Before 2015, we had nothing. That was distressing to me because there were too many women I couldn’t help.”

So why has it been so hard to get a high-performing women’s libido drug on the market? For one, HSDD is more complicated that erectile dysfunction. “Women are far more complicated than men in our sexual desire,” said Dr. Judith Volkar, a quality officer for the Department of Obstetrics and Gynecology at UPMC Magee-Womens Hospital in Pittsburgh. “Viagra works because it’s a plumbing problem. Women’s drugs work on your neurotransmitters.”

HSDD is diagnosed when a woman who used to have a healthy sexual appetite experiences loss of desire that causes her to become upset. Depression, stress, anti-depression side effects, a lack of attraction to her partner — these are not HSDD, according to Volkar. If a woman rules out these factors and she still doesn’t want to have sex (and she wants to want sex), she might have HSDD. Millions of women have it. Cultural and psychological factors (such as depression, stress, or trauma) contribute to HSDD, according to Volkar, but some women need a physiological boost. Hence, drugs.

Sadly, there is truth to the fact that many women’s libidos deteriorate over time.

The fanfare around Vyleesi has been cautious. Some doctors are unimpressed by its clinical trials. Also, unlike its male counterpart, Vyleesi can’t be swallowed in little blue pill form — it must be injected, like an Epipen, at least 45 minutes before you have sex. AMAG told me that they will give interested women a free trial package, which contains four injectables; refills will go “for no more than $99 thereafter.”

In self-assessment studies, AMAG reported that about 58 women reported some benefit from the drug in the first trial. According to the FDA, 25 percent of women reported an increase in desire, compared to 17 percent with a placebo.

There was no reported increase in “satisfying sexual events,” and 35 percent of women reported a decrease in anxiety over sex and libido issues, compared to 31 percent with a placebo.

Vyleesi’s high placebo effect might have to do with how it is administered. “If someone is going to go through the trouble, even if it’s with a placebo, by the time you shot yourself up with a drug you're gonna go ahead and do something,” Volkar said.

The decrease in distress Vyleesi produces might be psychological, according to AMAG Chief Medical Officer Dr. Julie Krop. “As the desire improves, the relationship starts to improve, those improvements then decreases distress,” she said.

“Some people are not willing to inject themselves with anything. That could definitely be a barrier,” Volkar said. “The other problem is that the results aren't great. It increased sexual desire and decreased stress, not by a large amount, but enough to be statistically significant...It didn’t increase the level of sexual events….it would be nice if the results were better.”

Vyleesi, which is only intended for use by pre-menopausal women, interacts with women’s neurochemistry by releasing dopamine associated with female sexual desire. It is not fully known how long it lasts, but you’re advised not to take more than one dose in 24 hours, or more than eight in a month.

So, will women use this stuff?

Mary (not her real name) is a mom and wife who said her libido has gone from good to meh over the years. She said she would be willing to try Vyleesi if she met the prescription standards.

“The injection is not that appealing. It’s like, of course women have to stab themselves and men just have to take a pill,” Mary said. “But, sure, I would at least try it to see if it was worth it or not. If it wasn’t great I’d say: okay I don’t need it. But if I could get my biological instincts more alert, then that would be more fun.”

Despite lackluster trial results, some doctors believe that trying something is better than nothing, even if there are some asterisks — 40 percent of women reported nausea at some point in the study.

“Seems worth trying to see if it helps. If it doesn't, forget it,” Dr. Don Berry, professor of biostatistics at the University of Texas, told me after reading the FDA results.

“The injection is not that appealing. It’s like, of course women have to stab themselves and men just have to take a pill.”

Critics like the National Women’s Health Network, a pharma watchdog nonprofit, have voiced concerns that the drug is profiting on women’s insecurities in an effort to produce a useless drug used to treat an intangible condition.

“I am more worried about the harm that their marketing may do than any harm that can come from the drug, because the drug appears to be pathetic. The results are pathetic,” Cindy Pearson, the organization’s executive director, said. “If women are suffering from a loss of libido that causes distress, I would like there to be an effective response to that — maybe with sex education, vibrators, sex therapy, maybe not, maybe it might be medicine — but I dont want that to be blown up into an ad campaign that says 10 million premenopausal women have this scourge, marketing it like it’s toenail fungus.”

A diagnosis of HSDD has long been criticized for the pathologization of normal human sexual variations. “It’s been in the diagnostic statistical manual for over 40 years, long before any pharmaceutical company got involved,” said Kingsberg. “It’s in the brain, so it's more challenging to understand the neurochemistry involved in HSDD… but that there’s still skeptics about whether HSDD even exists ignores science. It's 2019. We can’t keep doing this.”

Yet, naysayers persist. HSDD is not in the DSM-V, but some doctors argue that it’s highly similar if not essentially the same as the condition Female Sexual Interest Arousal Disorder (FSIAD), which is in the DSM-V.

Dr. Rosemary Basson, a clinical professor and director of the University of British Columbia's school of sexual medicine who has sat on FDA scientific panels for female libido drugs, argues that the conditions are very dissimilar — that there’s a big difference between anticipatory desire (i.e. “I can’t wait to have sex,” which Vyleesi aims to help) versus responsive desire (i.e. “I’m engaging in sexual activity with my partner and I’m starting to feel aroused”). Basson said that FSIAD is about a lack in responsive desire, unliked HSDD, which is about the former. So, in other words, Vyleesi is treating an unrecognized disorder.

“Aside from uncertain clinically significant benefit plus the 40 percent chance of nausea — the main difficulty is that the condition for which bremelanotide… has been approved is no longer accepted as a disorder i.e. as pathological or abnormal,�� Basson said. “FSIAD as defined by DSM-5 does not focus on absence of initial or anticipatory desire, and includes problematic responsive desire and arousal.”

One would hope women’s horniness would be top of mind for clinicians, investors, women, and men everywhere.

Other roadblocks are historical. In the early 2000s, testosterone patches were introduced to boost women’s libidos in clinical trials with some success. But the FDA cracked down on hormone-related treatments when estrogen and progestin treatments for decreased libido increased deaths and illnesses in women by 12 percent compared to a placebo.

“It’s clear that testosterone would work, but it would take a company years and years and billions of dollars to get the safety data they need,” said Dr. Tami Rowen, the education chair for the International Society for the Study of Women's Sexual Health. “It’s not going to happen.”

In 2015, the libido drug Addyi was introduced, becoming the first FDA-approved drug for HSDD. Everyone was excited, especially pharma giant Valeant, which bought the drug for $1 billion.

But Addyi, which was to be taken orally every day, faced catastrophic hurdles. Valeant’s stock tanked just one month later due to price gouging scandals. Based on the drug’s initial clinical trials, the FDA ruled that women couldn’t drink alcohol while taking it; patients had to sign a waiver promising that they wouldn’t drink. With sales plummeting, Valeant sold the product back to its developers.

Though further testing reversed the alcohol statement and reports of increased “satisfying sexual events” were high (at least compared to Vyleesi), the damage had been done. Addyi is still available, and still throwing star-studded parties celebrating female desire, but it’s considered a commercial failure for now.

Unlike Addyi, Vyleesi is taken as-needed only, thereby eliminating the stress of a continuous medication. Krop said Vyleesi learned from Addyi’s journey in its clinical trials phase.

“We did significant alcohol interaction studies based on precedent from Addyi, and we did not see any alcohol interaction,” said Krop.

One might hope women’s horniness would be top of mind for clinicians, investors, women, and men everywhere. Maybe Vyleesi will bring the excitement. At the very least, while Vyleesi leaves plenty to be desired, at least it has opened up discussion around female sexual appetite in the medical community.

“I actually think it's a good thing because it gets women talking about this,” Volkar said. “If nothing else it makes them ask their providers. Physicians do a poor job of bringing it up with their patients.”

Halley Bondy is a freelance writer.