Women's Sex Drive Pill Is Defended by FDA, With Caveats

  • Addyi approved in August, sold by Valeant Pharmaceuticals
  • Agency officials say women should be able to decide on drug

The Road Ahead for Addyi: Why Did Sprout's CEO Leave?

Approving a pill to boost women’s sex drive was the right decision and patients should be able to make their own call about taking it, the U.S. Food and Drug Administration said in an essay defending the agency’s move in a leading medical journal.

The FDA had previously rejected the drug, called Addyi, twice. Before signing off on the pill in August, the FDA said it had required more research on its risks. Developed by Sprout Pharmaceuticals Inc., it’s now sold by Valeant Pharmaceuticals International Inc., which announced two days after the drug’s approval that it would buy Sprout for $1 billion.

Addyi treats a condition known as hypoactive sexual desire disorder, defined as reduced fantasies and desire for sexual activity that clearly distresses patients. While only about 10 percent of women who take the drug benefit from it, they can tell for themselves if treatment is helping, the agency said in the essay, which was published in the New England Journal of Medicine Wednesday.

Alcohol Risk

The agency is also requiring more studies on the drug’s safety -- patients aren’t supposed to drink alcohol while taking the daily pill, for example. The medicine should be discontinued within eight weeks if symptoms don’t improve, said agency officials led by Hylton Joffe, director of the FDA’s division of bone, reproductive and urologic products. The officials also encouraged “responsible” prescribing by doctors, pointing out that the drug was approved only for women who haven’t gone through menopause.

“It’s impossible to know any drug’s full safety profile at the time of approval,” the officials said. “We believe this is a reasonable approach that balances safety and access.”

The drug hasn’t sold well in its first weeks on the market, moving only a few hundred prescriptions in the U.S., according to data from Bloomberg Intelligence.

The essay is one of the few times the FDA has made public comments explaining its review decisions following an approval. The officials said they decided to write the piece after some observers criticized the approval as taking too long, and others said it was the wrong decision to sign off on the drug.

Inside the FDA

There wasn’t unanimity in the FDA ahead of the decision. Some members of the FDA review team urged the agency to reject the drug, saying its benefits didn’t outweigh the risks, the agency said in the essay. At a minimum, additional studies into the drug’s alcohol interactions for women should be completed before the medicine was allowed on the market, the objecting reviewers said.

In addition, the agency has required Valeant to conduct three additional studies on how the drug interacts with alcohol when women are drinking, an area that was studied mostly in men during Addyi’s development. The drug carries a black box warning, the agency’s strictest, and women have to sign an agreement acknowledging the drug’s risks.

There will also be "enhanced" monitoring for side effects and potential harms including low pressure, fainting, accidental injury and death, the agency officials wrote.

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