US Regulators Approve Addyi, First “Female Viagra'”

The “female Viagra” Flibanserin, designed to treat women’s low sexual desire, finally receives approval from FDA on Tuesday, after two rejections. There’s a warning of serious side effects such as low blood pressure, fainting and fatigue. It is intended to treat women who have not yet entered menopause and who have hypoactive sexual desire disorder (HSDD).

A drug known as the “female viagra” has been approved by US health regulators, in what experts say is the biggest advance in women’s sexual health since the the advent of the Pill in the 1960s. Women who took the drug in a clinical study had an increase of about 1 sexually satisfying event per month compared with those taking a placebo.

Reuters also noted that Addyi will only be available through certified health care professionals and pharmacies because of its safety concerns.

“Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress”, FDA said in a statement released on August 18.

Providers must assess the likelihood of a patient reliably abstaining from alcohol before prescribing as there is an increased risk of severe hypotension and loss of consciousness when Addyi is mixed with alcohol, according to the FDA. While Viagra pills are generally taken when needed, Addyi is to be taken every night before bedtime.

The drug named flibanserin, will be sold under the common name “Addyi”.

“There are a number of FDA-approved options for the treatment of various sexual dysfunctions available for men, but much fewer for women”.

Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD).

Unlike the male Viagra, Addyi arouses the woman, not by increasing blood flow in her genitals, but by by targeting the pleasure centers of the brain, New Zealand Herald said.

Furthermore, patients taking Addyi said they felt less anxiety and stress tied to their HSDD.