When your Mojo is a No-Show, Can a Drug Make it Go-Go?

Bremelanotide (Vyleesi), the drug that was recently FDA approved, may end up being used by millions of women that are experiencing the monotony of monogamy as opposed to treating women who have hypoactive sexual desire disorder (HSDD.)  And that may not be a bad thing.

At a recent meeting with my staff at The Northwestern Medicine Center for Sexual Medicine I presented the scientific data that precipitated FDA approval of bremelanotide, an on demand drug indicated for the treatment of HSDD in pre-menopausal women.  I described how bremelanotide needs to be auto-injected in the thigh or abdomen forty-five minutes prior to anticipated sexual activity and works by stimulating the pathway in the brain, which results in the release of dopamine, the neurotransmitter that enhances sexual feelings. Essentially, bremelanotide turns the libido OFF switch to ON.” 

The overwhelming response of my staff comprised of female physicians, advanced practice nurses, and sex therapist was, “Wow, I can’t wait to try it!”

These are not women with HSDD, who by definition are very distressed by a lack of sexual desire, and are highly motivated to do something about it. These are women in loving long-term relationships who enjoy sex but are looking to feel the rush of incredible excitement and heart racing sex typically experienced in a new relationship.  While acknowledging that this drug is not approved for that purpose, we quickly realized that as medical professionals we would have to decide if “wanting to try it” would be a legitimate reason to prescribe it (for someone other than ourselves). 

The treatment of true HSDD is controversial. Some even argue that HSDD is not even a real thing. Those that acknowledge it as a medical disorder disagree if the approach should be pharmacologic, talk therapy or both. 

When flibanserin, the first drug to treat HSDD was released, there was a passionate New York Times op ed written by Emily Nagoski, the author of Come As You Are, asserting that HSDD should never be treated with a pill. I generally agree with her approach, and like many, if not most sexual medicine experts, my feeling is that true HSDD, (loss of libido not explained by painful intercourse, history of trauma, a medical condition, medication or partner issues), is complicated, multifactorial and requires a complete evaluation before determining a treatment course- a treatment course that ideally includes talk therapy with a trained, certified sex therapist.

But, having said that, there is a great deal of credible scientific research which supports the biologic component of HSDD, and in many cases there may be benefit from a little pharmacologic help (in addition to talk therapy) to give those critical neurotransmitters a push in the right direction. An intact libido depends not only on sociocultural, psychological, and interpersonal influences but on intact biology as well.

But, returning to the original issue, what about the woman who does not have HSDD?  What about the typical woman who used to have a terrific libido but has settled into the monotony of monogamy? In nature, the desire to have sex is driven by the need to reproduce. Once that is no longer an option or is biologically undesirable, there are a number of mechanisms in place that decrease libido resulting in the “cycle of sex”. In your twenties, it’s all about sex, all the time. During the baby- making years, it's sex with a purpose. And then, before you know it, the bedroom is a place where all we want to do is get a decent night’s sleep after a long day. Even if you love your partner. Even if he/she is sexy, interesting and wonderful. This is normal. But many women in long-term unions would love to have that “I have to have you RIGHT NOW “ feeling experienced in the early days of a relationship. Is she a candidate for this new drug? Should we, after informed consent that this is an off label use, and disclosure of possible side effects such as nausea, vomiting, flushing and in rare cases a transient rise in blood pressure deny the opportunity to our female patients who do not have HSDD but are looking to restore that new relationship excitement? We were hard pressed to come up with a reason why we would not.

Sildenafil (Viagra) is not recommended for men who do not have erectile dysfunction, and arguably doesn’t even have a benefit. Yet, a guy who desires an enhancer, or maybe just insurance that he will rise to the occasion, will often pop it like Pez in spite of possible side effects such as nasal congestion, muscle pain, nausea, dizziness, heart attack, death, and that infamous erection that doesn't abate for hours…  

Should a woman, once fully informed, also have the opportunity to enhance her sexual experience? Is denial of this drug just one more example of the disparity between the importance of female sexual pleasure versus male sexual pleasure? 

At this point, with no data and no clinical experience prescribing bremelanotide to women without HSDD, I don’t have an academic, evidence-based answer. But as an expert who has treated thousands of women, both with and without HSDD, I think I have a pretty good idea, for better or worse, how this drug is going to be used.

 

 

FDA Agrees: Now Is the Time for Women’s Viagra

EveryDayHealth.com June 2,2015

EveryDayHealth.com June 2,2015

“I’m just not interested in sex anymore.”

“I don’t think about sex.”

“I miss feeling sexual.”

Welcome to my office.

Of all the sexual problems my patients report, the loss of libido is by far the most common. The medical term for lack of lust is hypoactive sexual desire disorder, or HSDD: an absence of sexual thoughts, fantasies, or desire for sexual activity that causes distress or interpersonal difficulties. The last part is really important.

Not every woman who has zero libido cares or is motivated to do something about it. But millions of women do care, either because they find this loss of libido personally distressing or disinterest in sex has sabotaged a relationship or marriage.

It is perfectly normal to not want to have sex with a guy who smells like the zoo and with whom you don’t even want to be in the same room with much less share a bed. It is perfectly normal to not want to have sex if it is excruciatingly painful. But the woman with HSDD loves her partner, and things work just fine physically, but her libido switch is simply in the off position.

What Keeps Libido Strong

The biological cocktail for an intact libido includes not only hormones such as estrogen and testosterone, but also neurotransmitters that determine how often women think about, and desire, sex. While many neurotransmitters make a contribution, the essential ones are dopamine, norepinephrine, and serotonin.

Dopamine is all about desire. It’s dopamine that creates that feeling of “I want sex, I need sex, and I can’t stop thinking about sex.” Serotonin is all about keeping desire under control so you can stop making love long enough to go to work and do the laundry.

It’s all about balance — enough dopamine to want sex, and enough serotonin so we don’t want it all the time.

So essentially, HSDD is a biological problem. Currently, there are no FDA-approved medications to help women who have HSDD.

This week, the FDA is taking another look at flibanserin, a promising drug that has been shown in multiple scientific studies to help women with HSDD, but was turned down by the FDA in the past. Experts have been invited to speak at a public forum to explain why flibanserin should — or should not — get the FDA nod of approval. I will be one of the experts in Washington on June 4th to step up to the mic and explain how flibanserin works on the brain to increase dopamine and decrease serotonin levels. I will also emphasize that flibanserin is not for everyone. Flibanserin will not help, and should not be prescribed for,  the woman who has a dysfunctional relationship, painful intercourse, or a hormonal imbalance.

Approval of this drug has become controversial and in many ways has become a political issue rather than a medical issue. Many “experts” claim that HSDD is not real, but is a made-up condition so pharmaceutical companies can sell drugs. Yes, HSDD, like other female sexual problems is real, and I am offended that 26 drugs have been approved for male sexual health and none for women, other than to alleviate vaginal dryness.

5 Myths About HSDD That We Need to Debunk

Here are the facts to balance out the fiction:

Myth 1: HSDD is not a real medical condition.

There are more than 13,000 medical publications about HSDD dating back to 1977. Not to mention that anyone who has spent time in my office knows how real it is.

Myth 2: It is an exaggeration that there are 26 drugs approved for male sexual health.

Actually, there are 41 if you include generic drugs for men. But 26 is the number of unique medications.

Myth 3: Sexual problems are mostly due to interpersonal, psychological, or cultural/social issues.

Yes, all of those things are important, and a therapist or change of relationship is often the fix. But biology is also key. Science has shown that activity in the brain is different in women who have HSDD. It is clear that an imbalance of neurotransmitters is at fault. No amount of talk therapy is going to correct a biological imbalance.

Myth 4: Flibanserin doesn’t work.

Women receiving flibanserin in clinical trials reported a 53 percent increase in sexual desire, as measured by the Female Sexual Function Index (FSFI). Adjusted for placebo response, there was a 37 percent increase. This was a meaningful response for the women in the trial.

Myth 5: Flibanserin has too many side effects to justify giving it to healthy women.

There were more than 11,000 women in the flibanserin clinical trials, and they reported no serious side effects. Some women experienced fatigue, nausea, or sleepiness. In contrast, there were only 3,000 men in the Viagra trials, they had  serious side effects such as cardiovascular problems, visual changes, and a drop in blood pressure. Not to mention, men get to choose if they want to take a risk and take a drug to enhance sexual desire!

Women’s sexual health problems are real and deserving of research and development of new drugs. Flibanserin will not solve every sexual problems, but it will treat low sexual desire in a meaningful way and make a difference for millions of women. So stay tuned. I am optimistic that the FDA will not allow bad politics to trump good science.

UPDATE: Since this post ran, the advisory committee to the FDA panel voted 18 to 6 to recommend that flibanserin be approved. It was an exciting day speaking before the committee, and I was honored to be part of the process in a very small way. Many experts spoke, and to say the discussion was lively would be an understatement.

The FDA still must gave final approval before the drug will be released, and certain conditions must be met to ensure safety. But this a huge victory for women and a clear indication that the FDA appreciates that there is an unmet need.

PHOTO CREDIT: Meriel Jane Waissman/Getty Images

Dr. Lauren Streicher Will Teach You to Love Sex Again

This interview appeared in Chicago Magazine, april 2014

Your new book, Sex Rx, addresses female sexual dysfunction. How common is it?

It [affects] 40 percent of women and 60 percent of postmenopausal women. The number one mistake [they make] is accepting sexual dysfunction as normal.

What causes it?

Number one is low libido. It may be [due to] medication; it may be depression. It may start out that you’re having painful intercourse. Then of course you’re going to have decreased libido, because people don’t want to do painful things.

And what typically causes the pain?

Sometimes it’s endometriosis, and sometimes it’s genital dryness. [If] someone doesn’t lubricate, that very often is because of hormonal issues: menopause or birth control pills. [Also] you need a good blood supply to the vagina in order to have normal lubrication, and women with diabetes and heart disease often have a decline in their blood supply in that area.

How do you fix it?

It may well be if [a woman] uses the right lubricant, she’s going to be fine.

And if not?

Women are nervous about taking hormones. [But] local vaginal estrogen is safe for essentially everyone to use. We’re using this in women with breast cancer because the systemic absorption is so low that it doesn’t even increase their blood levels beyond the postmenopausal range.

Are there any recent breakthroughs that women should be aware of?

There’s a device called InTone that reproduces what a pelvic floor physical therapist does. There are a number of new products, like nonestrogen products for treatment of vaginal dryness, [that] most women are not familiar with.

So sometimes a prescription is necessary?

Would you say to a man who couldn’t maintain an erection that he shouldn’t consider Viagra? Right now there are 25 drugs approved for male sexual health, and other than the vaginal dryness drugs, there are zero approved for female sexual health. That’s a real problem.

Any promising drugs in the pipeline?

Flibanserin has been shown in the medical literature to have an impact on female libido. It is going back to the FDA [for approval] in a couple of months.

You say that most doctors are not up on these solutions. Why?

[Knowledge] is highly variable depending upon where somebody trains. At Northwestern, [sexual health] is not a part of the residency. I’m trying to change that. It sadly all comes down to funding.

Your book is incredibly thorough. I mean, you have a section on kosher lubes and on vajazzling.

Some of that I put in just to have fun.