Open/Close Menu
Discusses Women's Health

As some of you may have heard in the news, an advisory panel to the FDA recommended approval of a new drug called flibanserin for the treatment of hypoactive sexual desire disorder or HSDD. (Yes we have to give a medical name and call something a disorder in order to treat it; “diminished or absent libido” is not enough.) HSDD is the most common sexual dysfunction in women. Years ago I wrote a book about female sexual disorders which was titled, “I’m Not in the Mood: what every women should know about improving her libido.” I spent most of the book explaining that for many women the lack of sexual desire could be traced to negative education, inappropriate expectation, medication, depression, partner issues and pharmaceutical inaction. And at the time I wrote the book the only available libido medication was testosterone, but it was not produced for women by any pharmaceutical company. In 2004 Proctor and Gamble filed a new drug application for a testosterone patch for women, but the FDA did not approve it because they felt there was insufficient data on risk of coronary heart disease or breast cancer with long-term use. (This despite the fact that many studies had shown that in menopausal women, especially those who are taking estrogen, adding testosterone improves libido.)

In 2009, a German company, Boehringer Ingelhelm developed the drug flibanserin and tried to get an FDA approved initial new drug application for therapy of HSDD, but the company encountered problems demonstrating appropriate effectiveness. Apparently, the issue was the difficulty they encountered getting the women in the study to answer questions about their level of desire every single day. (The questions turned them off.) They gave up… Another company called Sprouts Pharmaceuticals (great name) took over the drug development and in 2013 resubmitted it to the FDA with new data. One of the factors they looked at was an increase in monthly satisfying sexual events (SSEs). (This gets rather complicated as one wonders how an SSE is qualified.) There is now controversy as to how effective this medication was in their studies. According to data that was presented to the FDA, flibanserin increased the number of SSEs by only one per month compared with placebo.

But, according to a guest editorial in the Journal OBG Management by a researcher who was involved in the development of this medication, there were issues in these calculations. Most of the participants in the trials were women who had been married an average of 10 years with an average age of approximately 36. He stated that among married women in this age group only 25% have sex more often than weekly and only 5.1% have sex four or more times per week. He also felt that some of the women were nonresponders to the drug (perhaps they had other libido lowering factors) and when they were lumped together with those who did respond, the magnitude of the drug’s response was greater. He states “In reality, approximately 25% of women in the flibanserin trials experienced an increase of four or more SSEs.” He also proudly stated that Sprout Pharmaceuticals tested the drug in almost 8000 women. (Most companies test their medications in 1500 to 2000 people for FDA approval.) He went on to say that the medication impacts a certain enzyme and there can be adverse interactions with other medications, especially oral medications used to treat yeast infections. He acknowledged that there will be a need to have restrictions if there is final approval of the drug, including a warning about use with alcohol. (I can see it now, a restriction not to use if you plan to drink and drive after sex!)

Over the years, I have found that in some women testosterone therapy does help treat HSDD. But because it is not FDA approved and there is no established pharmaceutical product for women, I have to have it compounded.

If indeed flibanserin gets full FDA approval and more data comes out to show that it is effective and does not have significant side effects, it will be more than welcome in my therapeutic choices to treat that oft heard distress call, “I am not in the mood!”.

Copyright © 2015 Judith Reichman | Contact Us | Legal Disclaimer and Site Policy | Los Angeles Web Development - Dream Warrior Group