FDA Approves Disputed Medication to Enhance Female Sexual Desire

Late Tuesday, the U.S. Food and Drug Administration (FDA) announced that it had granted approval to the disputed medication flibanserin (Addyi).

It is the first medication to treat acquired, generalized hypoactive sexual desire disorder (HSDD).

Consumption of alcohol while taking the medication presents serious risks. As such, the medication will only be available through certified pharmacies and healthcare professionals.

The medication will carry a Boxed Warning regarding the risks of taking the medication while consuming alcohol, taking moderate or strong CYP3A4 inhibitors or those who with liver impairment.

Use of the medication and alcohol can lead to hypotension and syncope. As such, the FDA’s approval comes with a risk evaluation and mitigation strategy.

“In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol,” the FDA said in a statement.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

The approval is based on the results of a 24-week study in 2,400 premenopausal women with HSDD. Treatment with the medication yielded an increase in the number of “satisfying sexual results,” according to the statement. For more information regarding the study, click here.

A public relations campaign called Even the Score, supposedly funded by the drug manufacturer itself, was launched to try to sway public opinion, according to a Medscape report. The campaign put forward the idea that sexism had played some role in the FDA’s decision not to approve the drug. In response, 200 healthcare professionals petitioned the FDA to not approve the drug given the potential dangers associated with its use.

This week, eight medical experts gave Time their take on the heavily disputed drug.

One stated her opposition to the drug’s approval given the fact that it had already been twice-rejected. “The drug hasn’t changed, the data hasn’t changed, and my opinion hasn’t changed,” said Leonore Tiefer, clinical associated professor of psychiatry at NYU School of Medicine. “I think it’s a disaster. It’s unsafe and it doesn’t work. That is all a drug is supposed to do. Work and be safe.” 

Dr. Holly Thacker, a women’s health specialist at the Cleveland Clinic, told Time, “Flibanserin is a game changer for women with hypoactive sexual desire disorder. I see it as one of the top health innovations for the coming year.”

Dr. Kenneth Paul Rosenberg, who is a professor at Cornell Weill Medical College, told Newsweek that although he’s happy to have the medication as an option, he has found that talk therapy can have better results than the results of the studies on the drug.

--Stephanie Vaccaro

References:

1. U.S. Food and Drug Administration. FDA approves first treatment for sexual desire disorder [press release]. www.fda.gov. 2015 Aug 18.

2. Sifferlin A. What 8 medical experts think about ‘female Viagra’. Time. www.time.com 2015 Aug 17.

3. Firger J. FDA approves “female Viagra” for low libido in women. Newsweek. www.newsweek.com. 2015 Aug 18.

4. Lowes R. ‘Female Viagra’ foes denounce PR campaign to win FDA approval. www.medscape.com 2015 Aug 10.