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U.S. regulators expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in 2015, following a lengthy and contentious review process.

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

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

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Additional specialists in female health were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

The drug was originally developed as an antidepressant but was considered unsuccessful during initial trials.

However, scientists noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

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

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the interaction. The research, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for older females.

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

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for HSDD to a new population of women who may find help.

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “This involves 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 climax of sexual pleasure.”