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The federal agency expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to age 65.

Before the announcement, the pill, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in two thousand fifteen, following a long and debated review process.

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

Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

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

Other women’s health experts were supportive 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 obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to address women after menopause who wish to engage in 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: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

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

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 antidepressant but was deemed ineffective during initial trials.

Nevertheless, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

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

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label advises waiting at least two hours after drinking before using 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.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

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

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage 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.

“It's unclear if that has to do with the intricacies of the medication. 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 clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, flibanserin could still broaden treatment options for HSDD to a new population of females who may benefit.

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

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause experience a wide variety of changes that can impact libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by 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? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the effects 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 treatment option.

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

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“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.

Other recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality 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 sexual pleasure.”