Health Care

FDA Approves Second Drug to Help Women With Low Libido

FDA Approves Second Drug to Help Women With Low Libido”

According to Vyleesi manufacturer AMAG Pharmaceuticals, 5.8 million premenopausal American women suffer from decreased sexual desire.

"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", said Hylton Bone, director of the Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products.

The approval from the Food and Drug Administration adds another drug - the other is a daily pill that received FDA clearance in 2015 - meant to raise women's sexual desires. The drug is self-administered through an auto-injector 45 minutes before having sex.

"They don't want to have desire all the time", she said.

"While HSDD is the most common female sexual dysfunction condition, it is largely under-recognized".

"Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it's more hard to treat", said Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University's Center for Women's Health.

Another difference between the drugs is that Addyi, an oral tablet, is taken once daily, whereas patients can take bremelanotide as needed, Krop added. Seventeen percent of those who took a placebo reported an increase in sexual desire. Side effects during the trial included headaches, flushing and nausea.

Because so many factors affect sexual desire, doctors must rule out other causes before diagnosing the condition, including relationship issues, medical problems and mood disorders.

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 drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s.

AMAG licensed Vyleesi from Palatin Technologies Inc. and under the terms of their agreement the FDA approval triggers a $60 million payment to Palatin, plus tiered royalties tied to sales milestones.

Vyleesi should also not be taken by anyone who is also taking the drug naltrexone, used to combat opioid dependency, because Vyleesi reduces naltrexone's effectiveness.

Women with high blood pressure or heart disease should not take the drug because blood pressure increases were observed during testing.

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.

Keep an eye on this pre-market jumper throughout the day to see if the drug maker will recoup any of its market losses since the bell. She had no role in Vyleesi's development. "And I think we have to give physicians more credit than that". "In fact, that didn't happen at all".

Vyleesi will join Addyi in women's small list of drug options that can boost their libido. To them, prescribing a drug for HSDD misguidedly reduces the complexity of human sexuality to a biological issue.



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