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Flibanserin: FINALLY a Viagra Option for Women?

From the Show: HER
Summary: A female version of Viagra has been a long time coming. What are some of the FDA's reservations?
Air Date: 6/18/15
Duration: 10
Host: Michelle King Robson and Pam Peeke, MD
Guest Bio: Phillip Sarrel, MD
Philip SarrelPhilip M. Sarrel, MD, completed his medical education at New York University School of Medicine, his internship at the Mount Sinai Hospital, and his residency at Yale New Haven Hospital. In addition to his many years on the faculty of the Departments of Obstetrics and Gynecology and Psychiatry at Yale University School of Medicine.

Dr. Sarrel has also been a Faculty Scholar in the department of psychiatry at Oxford University, Visiting Senior Lecturer at King's College Hospital Medical School at the University of London, Visiting Professor in Cardiac Medicine at the National Heart and Lung Institute in London, and Visiting Professor in the Department of Medicine at Columbia University College of Physicians and Surgeons in New York. He is currently Emeritus Professor of obstetrics, gynecology, and psychiatry at Yale University.

Dr. Sarrel is the founder of the Yale Menopause Program and the Yale Sex Counseling Service. Dr. Sarrel is a founding member of the International Academy of Sex Research, AASECT, and SIECUS, the Sex Information and Education Council of the U.S. He is also a founding member of the International Menopause Society and NAMS, the North American Menopause Society.

Dr. Sarrel's research interests have included the effects of transdermal estrogen in postmenopausal women with symptomatic atherosclerotic coronary vascular disease; nutrients and endothelial function; ovarian hormones and menstrual cycle-related migraines; female sexual function, and numerous other topics. He is the author or coauthor of more than 100 journal articles, 50 book chapters, and 6 books, as well as more than 50 abstracts.

Dr Sarrel is an Editor of Menopause, the Journal of the North American Menopause Society. He has served as an editor or reviewer for numerous medical journals including Maturitas, Journal of the International Menopause Society, Journal of Gender Specific Medicine, the American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology and the Journal of Clinical Endocrinology and Metabolism.

Dr. Sarrel continues to participate in Yale academic activities and serves as a consultant in menopause health care.
Flibanserin: FINALLY a Viagra Option for Women?
The drug Flibanserin was recently locked in a heated battle for approval from the U.S. Food and Drug Administration, raising controversial questions about why there are so many sexual enhancement drugs available for men and zero for women.

Instead of actually working like Viagra works for men (sending blood flow to the penis), Flibanserin acts on receptors to restore a "normal" level of sexual desire in a woman's brain.

You might think that sexual dysfunction is primarily a man's issue, but 43 percent of women suffer from some sort of sexual dysfunction and are looking for something to boost their mood.

At the beginning of June 2015, an FDA advisory committee voted 18-6 to recommend the approval of Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. A final decision will be made in August 2015.

So, does this mean that there's a new Viagra-like option for women, or are there still issues at hand?

Phillip Sarrel, MD, joins HER Radio to discuss the latest update on Flibanserin and what this means for women's sexual health.
Transcription:

RadioMD Presents:HER Radio | Original Air Date: June 18, 2015
Host: Michelle King Robson and Pam Peeke, MD

RadioMD. RadioMD.com. This is HER Radio starring acclaimed entrepreneur and women's advocate, Michelle King Robson and leading women's health expert. The doc who walks the talk, Dr. Pam Peeke on RadioMD.

DR. PAM: Is there a Viagra for women, Michelle? It's all over the newspapers.

MICHELLE: It's everywhere. Everywhere.

DR. PAM: Oh, my gosh. There is a drug that is going through its FDA approvals or disapprovals – whatever – it's called Flibanserin. All of the titles have been saying, "Hey, we finally have a Viagra for women." But do we? It's gone through is first FDA approval.

MICHELLE: Right.

DR. PAM: It won't be finalized until August. But what is this all about? This Flibanserin?

Dr. Phil Sarrel is always our "go to" physician and expert for all things women's health, hormones, menopause, perimenopause and beyond. He is a founder of the Yale Menopause Program and the Yale Sex Counseling Service, as well. He is a founding member of the International Academy of Sex Research. Oh, good grief! He's the editor of Menopause, The Journal of the North American --

MICHELLE: Enough already.

DR. PAM: I just love reading all of this. Alright. Let's just get to this. Dr. Sarrel -

DR. SARREL: We're using up all of the Flibanserin time.

DR. PAM: I know! Let's do it.

DR. SARREL: I have real problems with the way in which the press has picked this up. It is also true with a lot of things the media does, about menopause, about sex, about, hormones. Does it need to have a hook to get people interested? It has nothing to do with the way Viagra works.

Here's the difference. A man who has a problem getting an erection takes Viagra or Cialis or one of those drugs to increase blood flow to his penis and have an erection. That's a sex response. The studies we're talking about today are not to do with sex response, they have to do with sex desire. The drug that is in discussion and has been studied now for many, many years. They have actually spent almost a half a billion dollars on the research for this drug. It is a drug that affects the brain. It is not a hormone.

It is not affecting blood vessels the way Viagra does. It is affecting the way nerve discharge occurs in the part of the brain that is involved in sexual fantasy and sexual desire. The problem that it addresses is the problem of loss of desire and loss of fantasy. When you put both of them together – loss of desire and loss of sexual fantasy – then you have a condition that is called "hypoactive sexual desire disorder". That is what Flibanserin was developed to treat. It is not a rare problem, unfortunately.

Among women--and women who have been studied for this drug are all premenopausal women--essentially women in their mid-20s to their mid-30s. We're talking about a younger age group where you wouldn't expect there to be a lack of sexual fantasy or a lack of sexual desire. But it does affect a great many women. Some kind of sexual dysfunction affects about 40% of all adult women at any given time. Of those problems – whether it is a problem with responding or a problem with desire – the most common problem is the problem of loss of desire. Now, that's very common after pregnancy.

It is very common if a women is young and had a hysterectomy and lost her ovaries. Those women were not included in this study. But I do what to make a point right away. By the way, this point was not really emphasized in the FDA hearing about Flibanserin – 42% of the women in this study were on low dose birth control pills.

MICHELLE: That's what I was going to ask you. What about birth control?

DR. SARREL: Exactly. It is very important to know and understand that a woman can be put on a birth control pill that will wipe out her sexual desire and wipe out her sexual fantasy. It is not a rare event. It is an easy changeable occurrence because you really just have to change the dose of the pill. In this study, it will turn out there are women who are high responders to the Flibanserin. Those are not women who were on birth control pills.

The women who were on birth control pills, they showed a positive effect on what are called "sexually satisfying events". But it wouldn't have even been enough to go back to the FDA with the data. If you include all of the women – the 58% who were not on birth control pills – then, in fact, almost 60% are in the group which we would call good responders which means they were having about two times a month before treatment, before being in the study, about twice a month, when they would be having a sexually satisfying event.

But this was a marked decrease from what they had been accustomed to and they were upset about it. You couldn't be in this study if you weren't distressed over loss of fantasy and loss of desire.

DR. PAM: Aha!

MICHELLE: Yes.

DR. SARREL: That's one of the criteria. Sure, there are women who are going to have no sexual fantasy, no sexual desire, who aren't distressed about it. But in order to be in the Flibanserin study, you had to be really upset about it. And also there were no other major factors like marital distress.

MICHELLE: Nothing.

DR. SARREL: Or problems with the partner, or some drug that you were taking. On the other hand, the birth control pill – that is one of the things that I really looked into about this and I feel that that really is an important part. Because if someone who has the loss of desire and fantasy and is not on the birth control pill then, in fact, the Flibanserin has a good chance of being very powerful for her. For the women for whom it worked that is something else to know. The study was done for six months and it was done compared to placebo--the study that was just presented to the FDA, which is the third of the studies with Flibanserin.

Many thousands of women have been studied with this drug and it does increase desire and fantasy. But the question is, how much of a difference does it make and are there any bad effects? That is where the drug had been turned down in the past because this is a drug that had been presented three times before to the FDA and each time it was turned down mainly because the FDA was more concerned about the adverse effects. The adverse effects are it makes you dizzy, to drop your blood pressure and you can pass out, and have a problem with fatigue. The side effects are considerable.

DR. PAM: The other thing, too, is you can't have it with alcohol, right?

MICHELLE: You can't drink.

DR. PAM: Here's the joke. If you actually look at the ads, there is a man and a woman sitting there. She's holding a glass of wine. I'm thinking, "Okay. Have we not read the packing and all the rest of it?"

MICHELLE: Yes.

DR. PAM: I think it's really important for everyone – Dr. Phil Sarrel is our "go to" physician expert in all things women and hormones, especially all these phases of perimenopause and menopause in life and has really helped us understand the role of Flibanserin in a women's life as it relates to her libido, her sex drive, and whether or not this is really a Viagra for women. Which it is not. It is not the same thing as Viagra. It works through a different mechanism completely. The brain versus the actually gonads, as it were, in men. Although there are some women who probably think that was a brain, too. We're not going to go there. Things could just get ugly here.

MICHELLE: Off topic.

DR. PAM: Off topic. Next one! Alright. Dr. Sarrel, thank you so much for being on HER Radio. Once again, I'm Dr. Pam Peeke with Michelle King Robson.

MICHELLE: You're listening to HER Radio on RadioMD. Follow us on Twitter. Like us on Facebook. Stay well.
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