Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.Allen G. Breed/The Associated Press
The U.S. Food and Drug Administration on Tuesday approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s.
The drug's label will bear a boxed warning – the most serious type – alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
"This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all," said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.
Under a safety plan imposed by the FDA, doctors will only be able to prescribe Addyi after completing an online certification test demonstrating that they understand its side effects. Pharmacies will also have to be certified.
"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment," said Janet Woodcock, director of the FDA's drug centre, in a statement.
Sprout Pharmaceutical's drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
On one side, Sprout and its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug's launch in mid-October, doctors who frequently see patients complaining about a loss of sexual appetite will have a new option.
"Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with," said Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists.
The search for a pill to treat women's sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological functions all proved ineffective.
Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.
Women and their doctors will have to decide whether the drug's modest benefits warrant taking a psychiatric pill on a daily basis.
Company trials showed women taking the drug generally reported one extra "sexually satisfying event" per month, and scored higher on questionnaires measuring desire.