Addyi, the little pink pill that sparked a war over whether women were being left out of the Viagra revolution, goes on sale Saturday.
The drug, designed to restore a woman’s lost sexual desire, has earned a $1 billion payout for the company that makes it.
Addyi is a daily medication that can't be taken with alcohol or certain other drugs, and possible side effects could limit its appeal. But experts believe those restrictions could spur development of better treatments for women's sexual problems after more than a decade of neglect by most of the world's large drugmakers.
Kim Wallen, a psychology professor at Emory University, says Addyi represents a historic milestone that may open the door to more drugs targeting desire in men and women.
"This is the first time that a drug, for either men or women, has been approved strictly to increase sexual desire," Wallen says. "That legitimizes many other drugs that are in development."
The battle over its approval whacked the Food and Drug Administration from two sides — campaigners, often company-backed, who said the FDA discriminated against women by turning it down twice, and critics who said the drug didn’t work and could even be dangerous to women who took it.
In the end, the company, Sprout Pharmaceuticals, came up with just enough data to show the drug could help women, adding on average about one satisfying sexual encounter a month. The FDA reluctantly approved it, imposing an unusual number of restrictions on who can prescribe the drug and how they can prescribe it.
Sprout must specially train doctors and pharmacists who dispense it and keep track of any problems with women taking the drug. Only trained physicians will be allowed to write prescriptions for the pill.
The FDA is also requiring a strong warning to women that they should never drink alcohol while taking the drug and stressing the risk that it can cause sudden fainting — a special danger for drivers.
Women prescribed the drug, whose generic name is flibanserin, will be told to take it every day, unlike male erectile dysfunction drugs that are taken on demand. Doctors say this exposes the women to the risks of side-effects every day.
Soon after the FDA approval came, Canada's Valeant Pharmaceuticals International Inc said it would buy Sprout for about $1 billion plus milestone payments.