🔗 Share this article

U.S. regulators broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to the age of sixty-five.

Before this week's decision, the pill, Addyi (flibanserin), was only approved to treat low sexual desire in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the maker of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Other women’s health experts voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person consumes several drinks on a given day, the label advises skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a new population of women who may benefit.

“I believe it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”