The drug’s manufacturer, Sprout Pharmaceuticals, plans to market it under the brand name Addyi.
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About 2 million women are currently seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.
The female drug’s label will bear a boxed warning alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting.
In clinical trials, women who took flibanserin recorded a median increase of 0.5 to one more satisfying sexual events each month than those who got a placebo.
The big question now is how many women will use Addyi, which is also known as flibanserin and has been called the “pink Viagra”. They work by increasing blood flow all over the body, including to the genitals, helping improve a man’s physical ability to have sex.
Documents from the 4 June FDA advisory meeting describe the drug’s purpose as “treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women”. But now the US FDA has approved a pill for low libido in women finally bringing a solution for their sexual complaints. In fact, the agency approved the drug with a risk evaluation and mitigation strategy, or REMS, to ensure safety. Critics say the small benefit is outweighed by the drug’s risks.
The pill was originally studied as an antidepressant, but was repurposed when it was shown to increase levels of sexual satisfaction in women.
The company expects an Addyi (pronounced “addie”) prescription will cost between $30 and $75 a month for women who have health insurance, with the insurer covering the rest, based on policies that cover Viagra.
This is the first FDA approved treatment for sexual desire in men or women, according to CNN.
In addition, the FDA has asked the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.
The drug – Addyi from Sprout Pharmaceuticals – is actually the first drug approved to treat a flagging or absent libido for either sex. The drug was again rejected in 2013, and today’s approval was aided in part by women’s lobbying groups who claimed that the FDA was employing a gender-biased double standard.
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The chief executive of Sprout, Cindy Whitehead, co-founded the company with her husband Robert Whitehead in 2011 after selling another small drugmaker they had founded called Slate Pharmaceuticals which had received repeated warnings from the FDA about its marketing tactics.
