🔗 Share this article

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s move to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in aspects 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 hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, showed no additional risk of syncope. But medical professionals had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of females who may benefit.

“I believe it will benefit this population 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 universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause experience a broad range of changes that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating 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 recommended both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

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

Testosterone is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido are:

• getting more sleep
• exercising
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”