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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. (Thomas, 6/21)

The medication OK’d Friday by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drug makers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. The other drug is a daily pill. (Perrone, 6/21)

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” Hylton Joffe, director of the FDA Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in a statement. “Today’s approval provides women with another treatment option for this condition. As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.” (Cha and McGinley, 6/21)

Addyi was approved under intense pressure from advocacy groups despite a review by scientists at the Food and Drug Administration (FDA) that deemed it minimally effective and possibly unsafe. Vyleesi, which does not restrict alcohol use, is seen as having several advantages over Addyi, including tolerable side effects, rapid-acting nature and not having to take it every day, according to analysts. (Joseph, 6/21)

Unlike Viagra, which directs blood flow to men’s genitals, Palatin said Vyleesi works by activating pathways in the brain that are involved in the body’s sexual responses. The drug is self-administered through an auto-injector 45 minutes before having sex. (Turner, 6/21)

Vyleesi’s demonstrated increases in reported desire, measured on a five-point scale, are small. But AMAG Pharmaceuticals, the drug’s manufacturer, contends that even a seemingly marginal improvement can make a major difference for women with HSDD. The drug’s most common side effect is nausea, which affected 40% of women in clinical trials, and the FDA advises women against taking more than one dose within 24 hours or more than eight doses per month. (Garde, 6/21)

In clinical trials, the FDA said about 25% of patients treated with Vyleesi benefited from an increase in sexual desire score, compared with about 17% who took a placebo. About 40% of patients in clinical trials experienced nausea, most commonly in those who used the drug, and 13% needed medications to treat the side effect, the FDA said in a statement. “There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events,” according to the FDA statement. (Edney and Koons, 6/21)

About one in 10 premenopausal women in the U.S. suffer from hypoactive sexual desire disorder, according to Unblush, a website that offers women information on the condition. (Axelrod, 6/21)

One expert in female sexual health said it remains to be seen how widely Vyleesi will be used. "Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it's more difficult to treat," Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University's Center for Women's Health, told CNN. She had no role in Vyleesi's development. (Mundell, 6/22)

Bremelanotide is not the first drug to be approved for this purpose. The drug flibanserin, sold as Addyi by Sprout Pharmaceuticals, was approved in August 2015. However, in the wake of both fanfare and controversy, the drug has not been not widely used, in part because women couldn't take it with alcohol and health care providers had to be specially certified to prescribe it. "Based on our data, we don't have an interaction with alcohol, so we don't believe there will be a restriction," Dr. Julie Krop, chief medical officer of AMAG Pharmaceuticals, said of Vyleesi. (Nedelman, 6/21)