The Federal Health Advisory Board of the United States, with a vote of 18:6 on the 4th, determined that the therapeutic efficacy of a "female Viagra" far outweighs the potential risk of accidental harm, and recommended the approval of this drug by the US Food and Drug Administration (FDA), which is expected to become the first marketed drug used to promote female sexual desire.
This pink small pill, called flibanserin, is used to treat non disease related sexual dysfunction in premenopausal women and is an experimental drug.
Fluranexamide directly acts on the controlled pleasure zone of the female brain, thereby restoring the gradually declining sexual desire in women. At the same time, fluranexamide reduces serotonin levels in the brain and promotes levels of dopamine and norepinephrine.
More than 11000 women have participated in clinical trials of fluranexamide. The FDA review found that the number of satisfactory sexual activities among women taking medication has improved statistically, while the pain caused by low libido has also been relatively reduced.
We are all looking forward to it. Fluribenzamide is a safer and more effective drug, with significantly better efficacy compared to side effects, "said Amy Whitaker, assistant professor of obstetrics and gynecology at the University of Chicago.
The advisory committee stated that manufacturers must take additional risk control measures to ensure that doctors only prescribe this type of medication to women in need, and that these women are aware of the potential risks they may have to bear. Flubenzelin mainly targets premenopausal women, and its main side effects include nausea, drowsiness, hypotension, and fainting.
Christina Chang, an expert representing the FDA, requested the advisory committee to carefully weigh the benefits and risks of fluranexamide for women, as it may have adverse interactions with contraceptives and alcohol, leading to accidents, falls, and other injuries.
The Washington Post reported on the 5th that FDA experts attending the hearing also mentioned that this treatment may be abused as a "date rape drug" and that attention must be paid to it. The manufacturer stated that taking fluranexamide may cause women to move slowly and feel drowsy, but it is not impotence. In addition, in an animal experiment, flurebane once led to an increase in the attack rate of breast cancer tumors. The 18 month review period is not sufficient to assess the risk of cancer development.
For the development of the "female Viagra" drug, obtaining positive recommendations from the expert group has been a major victory, as it has been controversial due to its effectiveness and safety issues. Since 2010, the FDA has twice rejected fluranexamide.
The difficult process of approval for this drug has led to accusations from some women's groups of FDA's double standards and gender discrimination. It is reported that the FDA has approved about twenty drugs for the treatment of male sexual dysfunction, but has not previously approved any drugs for women. After obtaining FDA approval in 1998, Pfizer's blue pill "Viagra" has achieved good sales results and significantly improved the quality of sexual life in male populations.