Molecular Formula C20H21F3N4O
Molecular Weight 390.40
CAS Registry Number 167933-07-5
Flibanserin, a Medical Treatment for Female Hypoactive Sexual Desire Disorder
Flibanserin ( Addyi® ) is a new drug being investigated for the prevention of HSDD in woman. HSDD, is a relatively new term developed to describe Hypoactive Sexual Desire Disorder which basically means a woman whose is otherwise healthy has a lacking libido, or a lack of sexual desire. Studies show that about 10-20% of women face this problem and some say HSDD outnumbers men with sexual problems. Flibanserin is classified as a 5-HT serotonin receptor agonist and a dopamine D4 receptor partial agonist. It is a Non-Hormonal agent that in essence increases dopamine and noradrenalin while reducing Serotonin in the brain. This in return seemingly has a positive effect on a woman's sexual craving who was otherwise lacking in this area. The benefits of it being Non-Hormonal are that it will not have the problems associated with other hormonal treatments such as a negative altered mood among other issues.
Flibanserin, (or rumored trademark name Girosa or Ectris) created by Boehringer Ingelheim, a German Pharmaceutical company, was originally being created as an anti-depressant but after testing for such was found to be a poor treatment for depression. Similarly how Viagra® was being experimented with originally to treat high blood pressure and angina (a heart condition). Interestingly while females where being questioned about their trial experiences for depression, a large number noticed an unexpected positive side effect from Flibanserin. They discovered that many woman where reporting more sexual interest and overall satisfying sexual experiences than before. Apparently some woman who where taking part in the trials didn't want to stop the testing based on this fact alone. This led the company to clinically testing this new compound for this exact reason. Can it actually increase a woman's desire for sex?
Boehringer Ingelheim set out to test Flibanserin with several clinical tests. One test with almost 2000 women (half taking the placebo) was performed over a 24 week period. These women where pre-menopausal, of different walks of life, and none had any majorly depressive disorder. This was to ensure that Flibanserin was not working as a result of depressed woman simply feeling better thus an increase in sexual desires. What was found during this testing was that woman on average said that their pleasing sexual experiences went from 2.8 times a month to 4.5 times a month. However also during this time woman on the placebo experienced an increase to 3.7 times a month. The difference being almost 1 more sexual enjoyable occasion per month. They also determined that generally the medication started working after around a 4 week period being taken once per day, usually before bedtime. The amount of Flibanserin what was determined most appropriate was 100mg. Although these reports are based strictly on a users self report, later MRI's done on classified HSDD woman showed that there actually is chemical balance disordered within the brain and blood not flowing to those areas as well.
Side effects that where reported by some of the users where usually low to moderate. These where dizziness, anxiety, fatigue, dry mouth, insomnia, nausea. Not everyone who partook in the study had any of these but there were more occasions of these being reported compared to the placebo group and due to the fact that this compound is fairly new, there have not been nor could there have been any long term studies on side effects.
December 28th 2006
It was reported that Boehringer Ingelheim accidentally discovered Flibanserin's potential while trying to create a quick acting Anti-Depressant. Because many anti-depressants actually can lessen ones libido, during the testing they asked people if they had this. The men in the testing did not have any altered response but many women did. They also reported that they have started four large clinical trials with 5,000 women in 220 locations. These were named Orchid®, Daisy®, Violet® and Dahlia®. If all goes well they could seek FDA approval sometime in 2009.
November 16th 2009
It is reported that the four phase 3 trials for Flibanserin where reported at the European Society for Sexual Medicine. Results averaged in these tests showed woman had an increase in satisfying sexual encounters from 2.8 per month to 4.5 times per month. However the placebo group had an increase as well from 2.8 per month to 3.7 times a month. Side effects reported where some occasional mid to moderate nausea, dizziness, insomnia and drowsiness.
Flibanserin has not at this time been submitted to the FDA for approval. It may potentially be done so within 2 years. If it is, there are not guarantees that the FDA will approve its use. There have been rumors that it could become available in the UK by the Spring of 2011.
May 18th 2010
Boehringer Ingelheim Pharmaceuticals reported today that information from a phase three trial confirmed that a larger portion of pre-menopausal women with HSDD taking 100mg Flibanserin reported meaningful improvements compared to the group taking a placebo.
Of 1,378 pre-menopausal women patients suffering from HSDD taking flibanserin 100mg provided feedback from an indepth questionnaire stating that 48.3% after 24 weeks of treatment reported different levels of improvement as compared to 30.3% of the placebo takers. 40.5% of the Flibanserin takers also reported a meaningful benefit from the medication as compared to 25.2% of the placebo group.
On the Proposed date of June 18th 2010, a FDA's Reproductive Health Drugs Advisory Committee will determine on whether or not to propose the approval of Flibanserin to the FDA.
June 16th 2010
Today the FDA questioned the safety and success of Flibanserin and find that the drug was considered moderate for its acceptability. Other issues they were concerned about were Fatigue, sedation and drowsiness as they had been reported often during testing. There are also reported numerous drug interactions that may need more than just labeling to warn women. The FDA stated that "overall response rate...is not particularly compelling." also they stated concerns when the drug was taken with alcohol, antidepressants and hormonal contraceptives.
June 18th 2010
The FDA advisory panel voted 10 to one that flibanserin was not significantly better than a placebo, and unanimously that the benefits did not outweigh side effects like dizziness, nausea and fatigue... Although this was rejected in the USA, it is unsure what the Boehringer Ingelheim's plans are now. If they decide to pursue it in other countries or what their next step is regarding Flibanserin.
October 8th 2010
Boehringer Ingelheim has officially stopped the development of flibanserin. They still believe that the drug works but after the FDA panel vote earlier this year they believe that the efforts to gain approval are too difficult.
Since this last date it had been submitted to the FDA, and was rejected as well, it was sold to Sprout Pharmaceuticals who has put more testing towards it.
Feb 17 2015
Sprout Pharmaceuticals has announced that it has resubmitted flibanserin, a drug intended for hypoactive sexual desire disorder in premenopausal women to the FDA for approval.
Sprout Pharmaceuticals received additional requirements for the testing of the product back in 2013 and has since completed additional testing. In testing Flibanserin has shown statistical improvement in increasing a woman's sexual desire and an increase in the frequency of satisfying sex.
May 7 2015
A panel of medical experts is scheduled to meet on June 4th regarding Flibanserin. They will determine if they figure the drug should be approved for HSDD (Hypoactive Sexual Desire Disorder) The FDA will then strongly consider the outcome of this meeting to determine if they will approve this drug. The FDA is not required to follow the advise of these doctors but most often does.
June 4 2015
After much discussion, an FDA panel of advisory doctors have voted that the FDA approve the drug Flibanserin (Addyi®) for the treatment of low sex drive in women. The vote was 18 for and 6 against. While the FDA is not required to take the advice of this panel in their decision, it most often does so. This recommendation does not come however without some concern over possible side effects in users. If the FDA has a deadline of August 18th of this year to make a decision on it. The vote, while in favor of approval, may not be quite as close as it may seem. There where several people who voted yes but perhaps where hesitant in their vote due to what they perceived as modest benefits and or the potential for unfavorable side effects. Several people have also pointed out that this should not be referred to as "Female Viagra®" as the fundamentals on what it would be used for are different. Men using an erectile dysfunction medication are not being treated for their desire.
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