Addyi, pink pill made by Sprout Pharmaceuticals to boost sexual desire in women – a version of the male Viagra, went on sale on Saturday after the US Food and Drug Administration (FDA) had turned it down twice.
It has already earned $1 billion payment for its maker.
With generic name flibanserin, Addyi must be taken every day by a woman that wants to boost her sexual desire; but it must never be taken with alcohol or some particular drugs in order to avoid serious side effects. It was cases of side effects that made the FDA to delay its approval up to this time – something critics had used to negate its sales.
But campaigners had criticized the FDA for failing to approve the drug and accused the federal agency of discriminating against women for decades where sexual problems are concerned, while men have several sexual drugs with women having none prior to this time.
“This is the first time that a drug, for either men or women, has been approved strictly to increase sexual desire,” said Kim Wallen, a psychology professor at Emory University. “That legitimizes many other drugs that are in development.”
Wallen noted the approval of Addyi is a historic milestone in drugs that target sexual desire in women, with opportunities to encourage pharmaceuticals to develop more similar drugs.
Drugmaker Sprout Pharmaceuticals submitted more data to convince the FDA that Addyi would be very helpful to women. The agency eventually approved the drug, but with several restrictions on who can prescribe it and the conditions for its prescription.
Only trained pharmacists and doctors would be allowed to prescribe the drug, and doctors must be well-trained by Sprout before they are approved to write prescriptions.
Meanwhile, since the drug could cause fainting – a serious danger for women drivers, patients are warned not to take it with alcohol or certain drugs to avoid serious side effects. It must be taken every day, unlike male sexual drugs that are only taken when needed; making critics to say women face risks of side effects on a daily basis.
Canada’s Valeant Pharmaceuticals International offered to buy up Sprout Pharmaceuticals for about $1 billion together with milestone payments soon after news of FDA approval came.
