New Sex Drug for Women to Improve Low Libido Is Approved by the F.D.A.

The Food and Drug Administration has approved a new drug to treat low sexual drive in women, the only one besides Addyi, which entered the market in 2015.

The drug, to be called Vyleesi, will be sold by AMAG Pharmaceuticals and is intended to be used 45 minutes before sex, via an auto-injector pen that is administered in the thigh or abdomen.

“We’re obviously thrilled about being able to bring another option to patients,” said Dr. Julie Krop, the chief medical officer of AMAG, which is based in Waltham, Mass. “These women have suffered significantly, pretty much in silence, for a stigmatized condition, and many of them have not known that it’s a treatable medical condition.”

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For years, the F.D.A. has been under pressure to encourage more treatments for women with low sexual drive — a condition known as hypoactive sexual desire disorder. Medications for men experiencing erectile dysfunction arrived on the market two decades ago.

But these treatments for women have provoked controversy. The first product, Addyi, was approved amid an industry-backed publicity campaign painting detractors as sexist. But some opponents argued its risks outweighed its benefits. Addyi must be taken every day and cannot be taken with alcohol, which can cause fainting.

Soon after it went on sale, Addyi was acquired by Valeant Pharmaceuticals for $1 billion, which then failed to promote it. Valeant sold it back to its original owners in 2017 and the drug’s sales have been tepid.

Company officials declined to say how much Vyleesi would cost and said they would provide more details when the product goes on sale later this year. They said they expected insurance to cover Vyleesi on a scale similar to Addyi and to male erectile dysfunction drugs — coverage of those drugs by commercial health care plans is mixed.

The company, which manufactures other products for women’s health, estimates that nearly six million American premenopausal women suffer from low sexual desire, a condition that largely goes untreated. The company said that market could translate into about $35 million a year for every one percent of affected patients who use their product. The drug was developed by Palatin Technologies, which licensed it to AMAG to sell in North America in 2017.

Vyleesi, also known as bremelanotide, has some advantages over Addyi. It is to be used only before sex, and can be taken with alcohol. But the drug also has drawbacks — it does involve needle injections, and in clinical trials, 40 percent experienced nausea after taking it. In all, 18 percent of women dropped out of the trial, including eight percent who stopped participating because of nausea.

In addition, about one percent of the patients who took Vyleesi in the studies reported darkening in their gums and parts of their skin, which did not go away in about half of the patients after they stopped treatment. People with high blood pressure or who have cardiovascular disease — or those at high risk for cardiovascular disease — should not take the drug, the F.D.A. said.

The drug was shown to improve women’s self-reported feelings of desire and lowered their distress around having sex, but it did not increase the number of “sexually satisfying events” they had in a statistically significant way.

Dr. Krop, of AMAG, said the F.D.A. no longer requires companies that test drugs for low female libido to count the amount of sex women have as a primary evaluation measure. That’s because, she said, women with low sex drive continue to have sex with their partners, they just don’t enjoy it. “They’re oftentimes having mercy or duty sex because they want to maintain their relationship,” she said. “The problem is, they’re distressed about having that sex that they are having.”

Some drug-industry critics questioned whether Vyleesi was the latest example of a company promoting a pharmaceutical solution for something that is, in reality, far more complex.

The low-sex drive disorder has long been promoted by companies that were seeking to develop treatments for women. AMAG operates a website, unblush.com, which seeks to raise awareness about the condition; the maker of Addyi sponsors a similar site.

“I think it’s worth noting what’s an acceptable level of libido is socially influenced,” said Dr. Adriane Fugh-Berman, a professor in the department of pharmacology and physiology at Georgetown University Medical Center who studies pharmaceutical marketing. “Making women care less about the bad sex that they’re having is a dubious goal.”