The pink, ‘female Viagra’ has been approved by the Food and Drug Administration on Tuesday.
This is the first drug approved in the U.S. to treat hypoactive sexual desire disorder, targeted at premenopausal women. By comparison, there are 26 drugs targeting sexual dysfunctions with men approved in the U.S.
For many, this has been the main incentive to call the regulatory agency sexist and patronizing in trying to overrule the need for women to receive treatment for sexual dysfunctions. And while the approval of flibanserin was met with a heap of hurrays, the controversy surrounding the drug is far from over.
Two times in the past has the FDA rejected the approval of flibanserin as the clinical trials showed that the side effects of the drug exceed by far its limited benefits. In some cases, it did help women with hypoactive sexual desire disorder.
Yet, in most cases, the side effects reported where worrying: nausea, headaches, low blood pressure, fatigue, sleepiness. One last clinical trial gained flibanserin the approval of the FDA in June.
Developed by Sprout Pharmaceutical, the drug, now commercially known as Addyi, targets neurotransmitters to increase serotonin levels in the brain. This process is thought to play a role in reversing hypoactive sexual desire.
Once more, the exact mechanism that is triggered by flibanserin or Addyi is not known. Previously, the German pharma company Boehringer intended to develop flibanserin as an antidepressant. However, the process was dropped as the drug wasn’t effective. The cocktail of physiological factors, environmental circumstances, moods and other psychological traits, as well as the play of hormones could not lead to clear results.
In 2011 Sprout Pharmaceuticals bought the rights to the drug and developed it to become the first ‘female Viagra’. 13 percent of the participants in the clinical trials have ceased taking flibanserin as the side effects were too intensive.
If these side effects are really affecting the women’s general condition, is it safe for Addyi to be approved for that segment of the market that reacts positively to it and welcomes the slightest change in sexual relations with their partners?
That was a mind-boggling question. Now, Addyi will be available on the U.S. market as soon as October, allowing premenopausal women covered by medical insurance to purchase it for a copayment between 30 and 75 dollars.
Certainly, the approval of the first drug to combat female hypoactive sexual desire disorders is a win from a certain perspective. Yet, according to Leonore Tiefer of the NYU School of Medicine:
“I think it’s a disaster. It’s unsafe and it doesn’t work. That is all a drug is supposed to do.”
Alcohol consumption while taking Addyi is a high risk factor for the side effects to show. Addyi must be taken daily. For this reason, the FDA stated that the in-box warnings will highlight all of these risks for women to be able to make an informed choice.
Flibanserin will only be made available through a limited number of certified pharmacies and health care professionals.
Photo Credits: Yahoo