The Food and Drug Administration (FDA) has approved a female libido enhancer. It is given as a one-time injection and is intended for pre-menopausal women.

There are women who, for unknown reasons, have a reduced level of sex drive and could certainly benefit from safe pharmacological treatment, ”said Hylton Joffe of the FDA’s department for medicinal products in the areas of bone, reproduction and urology.

The manufacturer of the drug is AMAG Pharmaceuticals Inc. Julie Krop, who represents her, recommends using it about 45 minutes before the expected approximation. He explains that it is a synthetic hormone that activates relevant receptors in the brain and enhances neuronal activity.

  • This is not about a low state of desire, but about how it affects the quality of life and relationships of patients – says Krop – These women really suffer.

The FDA, announcing its decision, drew attention to the fact that it is not entirely clear how Vyleesi affects the brain to achieve the desired effect. Therefore, the office advises using it a maximum of once a day or eight times a month.

Doubts also exist around the very idea of ​​treating libido problems with pharmaceuticals. The roots of the problem can be psychological, physiological or external, including stress. According to statistics in the US, about 1 in 10 women have problems with libido.

Critics of the drug point out that most physicians who debated the definition of libido dysfunction during a specialized FDA panel were consultants or associates of Sprout Pharmaceuticals. It is a drug manufacturer that in 2015 created the first libido medicine for women – Addyi also known as flibanserin. There are also voices warning that Vyleesi is being introduced too early and the research used to approve it is carelessly prepared.

National Women’s Health Network Director Cynthia Pearson said her organization is disappointed with the FDA approval of the drug because “women don’t have enough information to make an informed decision about whether the drug will be effective and safe for them.”

Earlier this year, Sprout launched a campaign in the US with the slogan that women “have the right to desire.” “Why aren’t we talking about this?” Was the question in the campaign. The action was met with a protest from organizations dealing with women’s reproductive rights. They argue that you cannot use the language of civil rights to boost sales results.

Addyi is a pill for everyday use. Its side effects include dizziness and lowering of blood pressure when mixed with alcohol. In May this year, the FDA softened its tone against the drug. He advises not to mix it with the consumption of high-pitched drinks, but no longer urges you to completely reject such a combination.

The effectiveness of Vyleesi was studied for 24 weeks, a randomized double-blind trial with placebo control was carried out on approximately 1,200 pre-menopausal women with libido problems.

Most patients used the medicine three times a month, not more often than once a week. An increase in desire was recorded in 25% of women taking the drug. For comparison, placebo was effective in 17% of respondents. About 35% of respondents reported a decrease in one or more stressors, in the case of placebo it was about 31%. Side effects noted include headaches and indigestion.

The initial market value for such a drug is not estimated to be very high, however, by 2030, according to Barclays, it may sell a value worth even about 150 million dollars.

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