FDA on Friday approved a drug to treat premenopausal women with low sexual desire—a condition known as hypoactive sexual desire disorder (HSDD).
HSDD was first recognized as a gender-specific condition in 2012, according to the Los Angeles Times. About six million U.S. women experience HSDD, but few women receive treatment for the condition, Reuters reports.
That's in part because women who experience HSDD have far fewer options for treatment than men. There are currently more than two dozen drugs on the market to treat men with low sexual desire. In comparison, FDA's approval marks just the second time such a drug has been approved for women.
The first drug, Addyi, was approved in 2015 despite concerns raised by FDA scientists who found the drug was minimally effective and potentially unsafe.
FDA has faced criticism from advocacy groups claiming gender discrimination and neglect led to FDA's slow evaluation of drug's for women's sexual disorders. In response to those concerns, FDA recently held public forums and requested expert opinions on how to best treat women with HSDD and evaluate potential medications for HSDD. Experts recommended FDA evaluate the effectiveness of HSDD treatments by assessing the extent to which the treatment increases sexual desire and reduces distress, the Times reports.
FDA approves new drug for HSDD
The latest FDA-approved drug for HSDD is viewed as a better treatment option than Addyi, according to Reuters.
The drug, Palatin Technologies and Amag Pharmaceuticals' Vyleesi, functions differently than existing treatments for HSDD by addressing the physiological effects that some scientists believe affect sexual desire, the Los Angeles Times reports.
According to FDA, Vyleesi, an injectable drug, "activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown."
In clinical trials, 60% of patients using the drug reported an improvement in the levels of distress they felt over their low sexual desire, compared with about one-third of patients using the placebo. Based on that evidence, FDA approved the drug for use in premenopausal women who experience personal distress from low sexual activity.
To use the drug, patients inject Vyleesi into their abdomen or thigh using an auto-injector at least 45 minutes before engaging in a sexual activity. FDA recommends patients take no more than one dose of the drug within 24 hours and no more than eight doses per month. FDA said patients can decide the appropriate time to use the drug based on how long they experience the drug's benefits and whether they experience side effects, which may include flushing, headache, nausea, and vomiting. Patients who do not experience benefits from the drug should not use Vyleesi for more than eight weeks.
Unlike Addyi, Vyleesi does not carry a warning against use with alcohol. The drug's side effects include mild to moderate nausea, which lasts no more than two hours and typically occurs over the first three doses.
Analysts predict the drug could eventually see annual sales of about $1 billion. Company officials declined to say how much the drug will cost.
Hylton Joffe, who oversees urological and reproductive drugs within the FDA's Office of Drug Evaluation, said, "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. Today's approval provides women with another treatment option for this condition."
Sharon Parish, former president of the International Society for the Study of Women's Sexual Health, said Vylees' "availability will offer a new approach. There's a select group of patients for whom enhancing certain neurotransmitters is just what they need to kick-start a complex process. I think it's a good time to be in the field of sexual medicine."
However, Lori Brotto, a psychologist who directs the University of British Columbia's sexual health laboratory, cautioned that there is no definitive evidence that low sexual desire is caused by the chemical imbalance the drug seeks to address. That said, she added there is some evidence physiological effects play a role, and having a treatment option may encourage more women to seek treatment for a condition they would otherwise ignore (Healy, Los Angeles Times, 6/21; Joseph, Reuters, 6/21; Thomas, New York Times, 6/21; Perrone, AP, 6/21; Edney/Koons, Bloomberg, 6/21).
Get ready-to-use slides on women's health market trends for 2019
Want the latest information for your next women's health services meeting? We updated our most popular slides on women's health updated with the latest market trends in 2019.
This ready-to-use presentation covers everything from growth outlook and financial considerations to new care management priorities and technology innovations.