Drug to increase women's sex drive wins FDA approval
S E E D E D C O N T E N T
For women with low sex drive, the Food and Drug Administration has approved a new EpiPen-like drug that promises to boost libido.
AMAG Pharmaceuticals says that the drug, bremelanotide, helps women with hyposexual desire disorder, or HSDD. The FDA made the decision on Friday.
The drug is somewhat similar to medications used to treat erectile dysfunction in men, in that they are meant to be used "on demand" — when a person wants to be sexually intimate.
But that's where the similarity stops. Erectile dysfunction drugs work by increasing blood flow to a man's genitals. Bremelanotide, on the other hand, works by targeting a woman's brain chemistry.
The FDA has approved the drug Vyleesi to treat hyposexual desire disorder in women. AMAG Pharmaceuticals, Inc. Put simply, experts say women with low sex drive tend to have higher levels of brain chemicals that increase sexual inhibition, and lower levels of chemicals that lead to sexual excitement.
Bremelanotide is said to work to balance out those chemical levels. "It's about trying to restore this balance and tipping it in the direction of excitation when a woman wants it," said Dr. Julie Krop, chief medical officer for AMAG Pharmaceuticals.
Women are more complex than men sexually. It’s hormonal, but it’s not just hormonal.
But some sexual health experts argue that a woman's libido is much more than simple brain chemistry.
"Women are more complex than men sexually. It’s hormonal, but it’s not just hormonal," said Dr. Virginia Sadock, a clinical professor and director of human sexuality training in the Department of Psychiatry at NYU Langone.
Still, Sadock is not ready to dismiss bremelanotide entirely. "It’s obviously something women are interested in, and it's worth pursuing. But is it a miracle drug? Unlikely," Sadock told NBC News.
Measuring benefit
The drug, which will be marketed under the brand name Vyleesi, is an auto-injector, and is administered just like an EpiPen. The shot is self-administered to the abdomen or thigh at least 45 minutes before sexual activity.
In company-funded studies of more than 1,200 women identified as having HSDD, about 60 percent said they benefited from the drug, compared to about 35 percent who received a placebo.
But measuring "benefit" can get murky.
"When you're looking at things like desire, there's no blood test, no CT scan, no way to measure these things other than what's called a patient-reported outcome," Krop said. This means asking women how they're thinking or feeling, similar to how doctors study drugs for depression or anxiety.
Doctors say it's desirable for any drug meant to treat low sex drive to have modest benefits. "The women who come into my office are in long-term relationships. They’re not looking to all of a sudden have tremendous sexual desire, and to have sex every day," said Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Cleveland Medical Center. Kingsberg was a primary investigator in the studies of bremelanotide, and is a paid consultant for the drug company.
"They want to restore what they had," she said.
Side effects were minimal, according to AMAG. Some women reported that the injection made them feel nauseated. Eight percent of those study participants dropped out because of it.
The drug is only recommended for pre-menopausal women because it has not been studied in post-menopausal women.
What is HSDD?
AMAG says a woman would qualify for a diagnosis of HSDD if she were distressed by her persistent lack of desire for sexual activity. She, along with a physician, would have to rule out every other possible explanation for that low sex drive, such as relationship problems, stress, depression or fatigue.
"For these women to have had good desire, and then to have lost it, for no situational reasons, it’s very distressing. And it has an impact on their lives well beyond the bedroom," said Kingsberg.
Low libido is multifactorial.
AMAG estimates as many as one in 10 women has HSDD. However, those who treat women's sexual health problems say the true numbers are much lower.
"Low libido is multifactorial," said Dr. Lauren Streicher, medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause. She goes into a "deep dive" of the personal and medical history all of the women who seek her help.
"We have to address all of those other things that may be contributing," Streicher, who wasn't involved with work on the new drug, said. "Maybe they have a history of trauma. Maybe they're on an antidepressant that's killed their sex drive."
"Quite frankly, it's rarely just one thing."
But Streicher also welcomed possible FDA approval of the drug, which she said looks like will help women who truly need it.
"It's not that HSDD is not real. It's real. It's a question of what precipitated the HSDD and what are all of our options in terms of making it go away," Streicher said.
Some experts compare HSDD treatment to that of depression or anxiety . Some patients do well with psychotherapy, others do well on medication, while others might need a combination approach.
The only other FDA-approved drug meant to treat low sex drive in women is called Addyi . But Addyi never really caught on mainly because it comes with a warning that women should not drink alcohol while taking the pill, which must be taken daily.
When Addyi was green-lit by the FDA in 2015 , two distinct camps emerged: those who insisted that, because men had multiple drug options to enhance their sex lives, women were long overdue, and those who strongly questioned both the existence of HSDD and whether the pharmaceutical industry had any business dabbling in sexual desire.
Four years later, those camps remain, but appear to have met in somewhat of a middle ground. Generally, experts agree that it's perfectly normal for libido to fluctuate throughout women's lives, and that it's not necessarily a medical problem. They also concede that there does appear to be a small number of women who truly perceive that they suffer from low sex drive, and need far more than, say, counseling to rekindle the desire they once enjoyed.
"There is a chorus of women who are naysayers, and I feel that is a disservice to the interests of women," said Sally Greenberg, executive director of the National Consumers League, a nonprofit that advocates for consumers.
"To me, it means you are not listening to women."
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I'm not sure a needle puts me in the mood either.
"For women with low sex drive
It's a big problem for women who haven't met me!
Good one!
What happens if you overdose ?
I suppose there'd be a lineup.
True enough
I dare not think about it... LOL
Typed and erased, typed and erased. Like 6 times. I realized that every response that's going to come from me is going to be in woefully poor taste, so I'm gonna skip it.
No go ahead. I need to read them now.. do them all, LOL!
The drug — administered like an EpiPen — would be used as needed.
My initial thought is that if I cannot create the mood with my mediocre looks and acidic wit, then I am unworthy of the prize.
Not that this would not be of a benefit to those females suffering from such malaises ( though I believe it to be more of a benefit to the male perhaps ), I would rather researchers devote their time and effort to say, I don't know a cancer cure maybe.
I agree. I think that should do it for any woman.
That thought did cross my mind, but then again, I think that this will make them a ton of money.
As long as it is something they want, why not?
I agree, although it better be nicer to you than an epipen is. Those things hurt.
Well, I kind of want to laugh about that and I kind of don't want to.
When my daughter was going through some of the throes of lyme disease, she would go through out of the blue anaphylactic shock from things so we always had epi pens on hand (don't get me started on that epi pen asshole).
One time a pen would not fire. WTF????
Tried again, and again and again. No go.
Then studied it to see if I could find a problem.
As I moved my hand over the top, it fired, right in to one of my fingers.
Fortunately, the ambulance which was already on the way and was only 2 miles up the road in town would be there in seconds for her.
But I have to admit the purple looking finger for the next 24 - 36 hours was a bit disconcerting.