The first drug in the U.S. to boost women’s libido has been approved by the Food and Drug Administration (FDA) on Tuesday.
Flibanserin or as it will be commercially known, Addyi, is the first drug to help women fight against hypoactive sexual desire disorder approved in the U.S. However, it is specifically targeted for women who have not yet entered menopause.
Activist groups in favor of Flibanserin are welcoming the decision as a win for women, who, they claim, have been in the disadvantage until now in a market where 26 such drugs already exist for men.
The female Viagra, as it has been dubbed at times does not function as drugs targeting the male population do. It is intended to act at a neural level to boost sexual desire. And while the FDA gave its approval for Addyi to be released on the market as soon as October, the controversy surrounding the drug has many thinking twice.
Flibanserin has been submitted for approval twice before with the FDA. And it failed to obtain the said approval. The main reason is that flibanserin did not pass the clinical trials with significant effective results. Rather, the emphasis fell on the multitude of side effects which prompted some of the participants to quit the trials.
While some of the women reported an improvement related to hypoactive sexual desire disorder, many others have reported fatigue, nausea, sleepiness, low blood pressure, headaches.
Flibanserin was initially tested as an antidepressant researched by German drug manufacturer Boehringer. As the drug did not prove its efficiency, the clinical trials were dropped and in 2011, Sprout Pharmaceuticals bought the rights for flibanserin.
The journey of creating the first female Viagra thus started. And while in June the FDA has already approved flibanserin under the condition that strict supervision of possible side effects is being conducted, Sprout Pharmaceuticals announced that Addyi will be made available in October.
According to estimates, women that are not yet in their menopause will be able to purchase Addyi for 30 to 75 dollars copayment in case they are insured. According to the FDA, the drug will only be made available at carefully selected pharmacies and only certain health care professionals will be able to prescribe it.
While under treatment with Addyi, women are recommended to not consume alcohol. Addyi must be taken daily for effective results in treating hypoactive sexual desire disorder and preferably at night, when there is less chance of the side-effects to be felt.
Careful consideration is advised before deciding to start treatment with this drug. Your physician may help you make an informed choice.
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