Ariana Eunjung Cha Laurie McGinley, Washington Post: June 21, 2019
The Food and Drug Administration on Friday approved sales of a new drug intended to enhance sexual desire in women.
Marketed as Vyleesi, also known as bremelanotide, the medication is a shot that comes in a push pen device that can be self-administered as needed for premenopausal women who experience marked distress as a result of low 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,” 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.”
Vyleesi activates certain receptors, but the mechanism by which it improves sexual desire and related distress is unknown. Patients inject Vyleesi under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. Patients should not use more than one dose within 24 hours or more than eight doses per month.
One study estimated that as many as 1 out of 10 women may have low sexual desire, and the FDA several years ago convened a meeting to better understand the impact of female sexual dysfunction.
Critics have pointed out that nearly all of the doctors on the recent panel that defined HSDD were consultants or advisory board members for Sprout Pharmaceuticals, the drugmaker that introduced the world to the first women’s libido drug, Addyi, also known as flibanserin, in 2015.
On Vyleesi, which was approved Friday, several women’s health advocates said more information is needed before approval. They noted that the FDA had not convened an advisory panel to scrutinize the drug.
“It is unfortunate that the FDA decided to approve this drug despite the skimpy peer-reviewed data and complete lack of long-use safety information,” said Diana Zuckerman, president of the National Center for Health Research. “The good news is that it doesn’t need to be taken every day, the way Addyi does. The bad news is that the public can’t have confidence in the safety of the drug because we don’t have access to long-term safety information about it.”
Cynthia Pearson, executive director of the National Women’s Health Network, said the group was “disappointed” by the approval and said that women “simply do not have enough information to make an informed decision about whether the drug is safe and effective.”
Earlier this year […]