On June 18, 2010, the US Food and Drug Administration unanimously voted against the certification of flibanserin. Five years later, on June 6, 2015, the same commission approved it as a new medicine (18 for and 6 against). And on August 18, 2015, flibanserin under the commercial name Addyi was officially admitted to the U.S. market. In all the world's media, a heated discussion of the drug immediately began, and with the light hand of the press (perhaps not without the influence of marketers at the pharmaceutical company Sprout Pharmaceuticals), the "miracle" drug was dubbed a "Viagra for Women".
Addyi is positioned by its manufacturers as a means to strengthen sexual desire in women in the preclimactic period. The history of the drug's introduction to the market is interesting for three reasons: first, it is still completely unknown whether flibanserin has any physiological effect on women's sexual arousal. The most detailed overview of all the studies that have been conducted, containing the general scheme of action of the drug, was published by Stephen Stahl in 2011 in The Journal of Sexual Medicine, after the first USFDA hearing. In general, the mechanism of action of Addyi does not differ from some of the known antidepressants (see details below), for example, agomelatine (Valdoxana).
The second reason is that flibanserin is one of the few (and possibly the only) drugs recommended by the FDA based solely on the subjects' self-reporting of their sexual desire and subjective self-assessment of their level of sexual satisfaction. However, the advantage over the control group receiving the placebo was only about 10 percent!
The third reason is that Addyi has become more than just one of the many medicines, it has become a symbol and a tool for the struggle of feminists for their rights. The biggest support in lobbying the pharmaceutical company Sprout Pharmaceuticals was provided by the feminist movement for equality of women in the field of treatment of sexual dysfunction Even The Score. The activists criticized the FDA, saying that it has already approved many funds for the treatment of erectile dysfunction in men and none of the similar drugs for women.
But let's get this straight. Flibanserin was first synthesized in 1995 by pharmacologist Franco Borsini in the research department of the pharmaceutical campaign Boehringer Ingelheim in Milan, Italy, as an experimental antidepressant. However, clinical trials have shown that although the drug is indeed able to regulate the production of neurotransmitters, it does not produce significant results in the treatment of depression. However, it has improved mood, especially in women. Additionally, one study found that fliesubancerin was thought to affect sexual behavior. Women tested among many other tests also completed the Arizona Sexual Experience Scale. Flibanserin users were found to have higher scores and to be more likely to experience sexual desire, sexual satisfaction, and higher evaluation of the intensity of flibanserin use.
These results have led to an extensive research program on flibanserin as a libido stimulant. It started in 2008, but used a controversial methodology - women who took the drug kept detailed diaries where they subjectively assessed their level of sexual attraction. The results of this work were twice rejected by the FDA, as they were not found to be statistically reliable.
Disappointed after another refusal of the FDA in the future of a new medicine Boehringer Ingelheim sold the rights to it in 2011 to Sprout Pharmaceuticals, which now, after the long-awaited approval of Addyi, immediately received a proposal from the largest pharmaceutical concern Valeant Pharmaceuticals International, Inc. on the takeover. The deal is estimated at 1 billion dollars.
What did Sprout Pharmaceuticals do? To begin with, they changed the research methodology. Their scientists, unlike Boehringer Ingelheim representatives, refused from attempts to put a neurophysiological basis under the observed effects of the drug and concentrated on proving them as such. Women in the experimental (Addyi) and control (placebo) groups completed the Female Sexual Function Index every 28 days, where they answered questions about their past sexual experiences and assessed their sexual desire on a five-point scale. Also, they noted the number of satisfied sex acts and the level of negative stress (distress) from low libido.
The results were rather mixed. For example, before the study began, women on average had 2.7 satisfying sexual acts in 28 days. In placebo users, this level increased to 3.7 and in Addyi users to 4.5. Only slightly more than 10 percent of women in the experimental group reported increased sexual desire and decreased distress from low libido. However, for reasons that are not clear, these new findings convinced most of the experts in the commission. Perhaps not the least in changing their position was the support of the drug by the feminist movement.
It is important to note that female sexuality (as well as male sexuality) is a rather complex multilevel phenomenon. It includes psychological, physiological and environmental factors. It is known that depressive reactions (in this case we do not talk about depression as a mental illness), depressed mood, severe stress, overload, etc., lead to a reduction, if not complete loss of sexual desire. Previously, physicians have dealt with these problems by relieving stress, increasing overall body tone, and taking individual psychotropic medications.
These results have led to an extensive research program on flibanserin as a libido stimulant. It started in 2008, but used a controversial methodology - women who took the drug kept detailed diaries where they subjectively assessed their level of sexual attraction. The results of this work were twice rejected by the FDA, as they were not found to be statistically reliable.