🔗 Share this article

The federal agency expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Before the recent news, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

Flibanserin was first approved by the FDA in two thousand fifteen, following a long and debated review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other specialists in female health 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 menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the enhancement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, scientists observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of women who may benefit.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

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

“I would have no problem recommending 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.

Additional recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• 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 OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”