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The federal agency expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to the age of sixty-five.

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

This medication was first approved by the FDA in 2015, following a long and debated review process.

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

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

Additional women’s health experts were supportive for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance 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 seeing a major effect?”

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

Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers observed positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment 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 serious safety warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not originally approved for older females.

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

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

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

But it is not a magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.

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

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

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes 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 personal habits should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “This involves knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”