You may have heard, I made the news…and, you did, too.
October 28, 2014, the FDA held a landmark 2 day conference in Silver Spring, MD. It was the first time Female Sexual Dysfunction had the government’s and the pharma world’s undivided public attention.
This event was in response to criticism that the FDA is gender imbalanced. In March 1998, Viagra was approved by the FDA for erectile dysfunction in men. Since then, a total of 24 drugs have been approved for male sexual dysfunction.
0 drugs have been approved to address female sexual dysfunction.
Some who keep score say 24-0 isn’t acceptable.
In January of this year, 4 congresswomen sent a letter to the FDA commissioner, who happens to be a woman. This letter was to bring the FDA’s attention to a gender disparity in willingness to undertake risk.
Flibanserin is a drug that was first developed by Boehringer Ingelheim. It was originally investigated as a possible anti-depressant.
Original anti-depressant studies on both men and women showed that the participants had little sexual dysfunction at the end of the trial. That’s when scientists did a happy dance. Could this possibly be the first female Viagra?
Flibanserin promotes dopamine (libido enhancing) production and dampens serotonin (libido restraint) production. There are no hormones in Flibanserin.
Flibanserin brings the brain into chemical balance between excitement and inhibition. (This is known as the ‘Kinsey dual control model.’) It would seem logical to conclude that some women with low sexual desire are heavy with the inhibition chemical, serotonin.
Flibanserin was denied approval by the FDA in October, 2010, in spite of favorable studies which proved its effectiveness and significance. 5,000 women in the US, Canada, and Europe took a 100 mg tablet once a day at bedtime. The non-placebo group went from 2.8 positive sexual experiences per month to 4.5, a 62% increase in sexual pleasure.
The FDA rejection was due to the side effects which are dizziness, nausea, fatigue, constipation and insomnia. Also, it was cited that the secondary function of enhanced sexual desire was not proven.
The 24th drug to be approved by the FDA for male sexual dysfunction, Xiaflex, has side effects of heart attack, sudden death and penile rupture (OUCH!). Viagra’s side effects include heart attack and stroke, which makes sense because it affects blood flow.
This is the reason the 4 congresswomen wrote a letter to the FDA ending with this statement, “We urge careful review employing the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation.”
After the initial FDA rejection, Boehringer Ingelheim sold Flibanserin to Sprout Pharmaceuticals, headquartered in my homestate of North Carolina. Sprout resubmitted Flibanserin for FDA consideration in June, 2013 with a total of 11,000 test subjects.
There has not been formal approval, but the FDA has given Sprout guidance. They would like to see a study on whether Flibanserin impairs a patient’s ability to drive.
In my opinion, this drug will be approved, probably within the next year. A low libido woman will need to weigh the benefit and risks to decide for herself if she wishes to pursue a chemical romance. I think this information is good to know as you begin to evaluate.
Sharing with: Let’s Get Real Party with Calm.Healthy.Sexy
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I’m glad that women will at least have an option to consider. It’s more than we have now!
It is very good to have options, especially since everyone’s situation is different. It may work for some and not others as is usually the case with drugs. It’s a start toward recognizing that women are sexual creatures and it’s OK.
I’m 32 years old. I’ve been with my husband for 14 years now and I have never had a desire for sex my entire life. I have never experienced what it’s like to desire sex or have sexual thoughts or fantasies. About a year ago, I learned that women actually get an erection type reaction, also known as arousal! I have never been aroused either. I have never experienced any changes in my clitoral or vaginal area. I don’t make any lubrication. I had my hormones checked even though this has been a lifelong struggle. I’m only 32 and my hormones were in a normal but low range for both estrogen and testosterone.
I tried testosterone cream for a few months and it only helped some with feeling more energetic overall since I’m often easily fatigued with daily living duties. It had no change in my desire much less an arousal response from my body. I’m in a very loving marriage where I feel very safe and commited and loved. We are faithful to our savior Jesus and have a solid spiritual foundation. I have never had any sexual abuse or hang ups. I can not find any psychological or physiological reason why I have 0% desire and have never experienced any level of arousal much less an orgasm.
I think you would need desire before you could reach arousal before you could then reach an orgasm. I’m searching blogs and Google and websites looking for answers. I’m not catholic so I’m fairly sure God hasn’t called me to be a nun but as far as sexual abstinence goes… It would be easy for me to live a life as a nun in that sense because I feel physically like a 5 year old body sexually living in an adult world. It just seems like my sexual side never developed even though the rest of me did.
I wonder if this medication could help start the development into adult sexuality from childhood asexuality. I love my husband so much and I want so badly to be more engaged and passionate and initiative with sex and I want to enjoy it too. It’s hard though when your body just doesn’t respond and even thinking sexual thoughts takes deliberate mental power and constant refocusing because it just doesn’t ever care to go there. The thoughts are not captivating or enticing or entertaining enough to keep my attention even though I am purposefully trying.
If there is anyone who can help please send me the resources. Again… This has been the norm for me lifelong. I didn’t developed a lack of drive or a decrease in arousal.. I NEVER HAVE HAD IT to begin with and I married my husband young. Even through puberty I never had a desire for sexual relations. I did developed nomtay though otherwise. Everything I find online is geared to post menopausal women who “lost it” and there is virtually no information out there for people in my situation who never had it and have no physical social or physiological reasons for lacking it. 🙁
Ashlee,
I hear your frustration and pain. I know this affects your husband, as well.
I know this sounds counter-intuitive, but low-libido women can experience arousal and then desire. It is different story with men. They nearly always have desire first. However, women are different from men. Sometimes, it’s after you start to ‘fool around’ that interest starts to build.
Now, what you have described seems more complex. Have you seen a hormone specialist, not just had your hormones checked by a family physician or gynecologist?
There are other women out there like you. You are not ‘weird’ or ‘abnormal.’ You just need to keep searching for answers. Have you prayed for God to send you the answers? Prayer can reveal remarkable insight from God.
I will see how I can address this for you in future posts.
I have been praying about it even before I was married. I have always felt abnormal or broken. I don’t know what it a a hormone specialist is because many obgyn have hormone therapy listed as part of their practice. I have only discussed my sexuality with my obgyn. My doc was able to help with the tearing painful sensations I had ALWAYS had with sex. It was thin tissue at the 6 o’clock location of my vaginal opening. No matter how much lube or how slow and gentle we proceeded it had always been painful with a burning and sometimes bleeding even sensation. She RX me topical estrogen for just the thin area twice a week and that has helped plump up the tissue causing significantly less pain and sometimes none! The testosterone cream we tried didn’t do anything for my sexuality. It did give me some energy though but I stopped taking it because I didn’t like the side effects in comparison to just a little extra energy. I wish there was more information out there about women who have never matured into a sexual being from childhood like myself. Where they have never experienced a libido or an arousal or sexual thoughts. Regardless of how much my husband stimulates me nothing Changes. No swelling, no lubrication, no increase sensations. It’s feels the same as if I’m washing myself… Just like normal delicate skin. Anyway thanks for considering future post to help find information. I can google some hormone specialist again but I always end up with obgyn or urology doctors in the list including the one a already see. My insurance also is set up that I have to stay in network. I just keep searching as I’ve been doing for years. Thanks.
Ashlee, I am going to email you in private.
I emailed you back.