Flibanserin Submitted For Another FDA Approval

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The Food and Drug Administration has received a new application from Sprout Pharmaceutical for approval of Flibanserin as a libido booster for women. The FDA has twice refused approval of Flibanserin because of side effects, which included fatigue, dizziness and nausea, and also because of lackluster effectiveness. Sprout re-filed its application and included new information that the FDA had requested from them about how Flibanserin affects the ability of women to drive.

The last time Sprout sought approval, 10 percent of the women tested reported sleepiness as a side effect. Sprout undertook new testing and the new data was submitted to the FDA for its review. Flibanserin is reported to stimulate the brain chemicals linked to appetite and mood.

The Diabetes Connection

Women with type 1 or type 2 diabetes might have difficulties with sexual desire and sexual fulfillment, as do many women without these chronic health conditions. Female sexual dysfunction currently has no “little blue pill” to treat it. Men have had Viagra, and various other pills, to treat their sexual dysfunction when it is caused by lack of blood flow. Women’s sexual dysfunction is more complex because in many instances it involves much more than blood flow. With women, hormones and other simple biological functions come into play, and these issues are not totally understood by the researchers; therefore, the search for a helpful aid has been a long and difficult process for researchers.

What is Flibanserin?

Flibanserin is a drug that was first tested as an antidepressant. Once it was discovered that Flibanserin affected both the inhibitory and excitatory regions of the brain, then a new view was taken of the drug. Antidepressants work on the serotonin level in the brain (inhibitor section), which might make sexual dysfunction even worse. With Flibanserin, there is hope that there is a balance between the inhibitory (serotonin) and excitatory transmitters (dopamine and norepinephrine) of the brain. A good blend without excessive side effects would big a huge positive for the 1 in 10 women who suffer from sexual dissatisfaction.

Stats on Women with Diabetes and Sexual Dysfunction

It is reported that approximately 35 percent of women with diabetes have some type of sexual dysfunction, which can be related directly back to their diabetes. Approximately 40 to 50 percent of these women might have difficulties due to nerve and small blood vessel damage. The exact numbers on these causes are not known. It has long been recognized that women’s issues with sexual dissatisfaction (or inability to enjoy sex to the point of orgasm) has not been addressed. Or, if addressed, no good solution has come about. There has been a big imbalance between the research done with regard to men and sexual dysfunction and women and sexual dysfunction. The two sexes are totally different, anatomically and mentally (as we all know), and the ways to address their issues cannot be the same.

What is Hypoactive Sexual Desire Disorder?

Hypoactive Sexual Desire Disorder is simply a string of words describing the lack of sexual desire of a woman. Just a typical day in the life of a woman can cause HSDD – getting the kids off to school, getting to work on time, being the boss or meeting the boss’ requirements, eating the right foods at lunch, getting off work in time to pick up the kids, avoiding the drive thru no matter how tired you are and going home to fix a nutritious meal for the family, getting the kids to bed. If a partner is in the picture, they have their stresses as well, and their stresses and your stresses both affect your love life. If you are a single female and working towards that partnership at the law firm, trying hard to make that next house sale, trying to get all those numbers ready for the accountant, you have the very same stresses. Stress causes HSDD, in many cases. Major upheavals in life – divorce, death of a loved one, diagnosis of a serious illness — can cause sexual dysfunction because these are life-altering events that require major adjustments. Seek help. Ask your doctor for their recommendations on things that can help you with your HSDD, especially if it is causing problems in your life.

Current Medications Recommended for Female Sexual Dysfunction

Both of these medications are well-known antidepressants, but are not known to inhibit sexual drive or sexual satisfaction, as do the paroxetine and fluoxetine antidepressants.


Counseling with a qualified sex therapist might be recommended by your doctor. Their role will be to educate you about techniques, relaxation, positive mental imaging, relaxed mental state, and possibly give you recommendations for reading. Reading Fifty Shades of Grey or seeing the movie might even be recommended. Anything that will make a female more relaxed and more receptive can help.

Hormone Treatment

Estrogen has been used in the past for female sexual dysfunction, estrogen that addresses the entire body, which would be administered as a patch, spray, pill or gel. This type of hormone treatment has been known to affect the brain function and mood factors in a positive way for some women, but without outstanding success.

At times, no matter what resources are used to treat female sexual dysfunction, it just does not work. By having pharmacy companies work to address this important health issue as it relates to women who have diabetes and those who do not, it will, hopefully, lead to a solution in the near future.

One thought on “Flibanserin Submitted For Another FDA Approval

  1. Trina

    Hey, that would be great. A little blue pill for women. I read years ago that the majority of testing for new drugs was done on men and then they tried to apply the results for the use of the medications in women. Didn’t work. At least they got a head start in this — realizing that what works for a man does not always work the same for a woman. Maybe if they work hard at it, they’ll come up with something for women. This article makes it sound hopeful.

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