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The federal agency widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to 65 years old.

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi praised the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other OB-GYNs were supportive for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “quite reasonable” given the existing research.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

This medication was first created as an medication for depression but was considered unsuccessful during early studies.

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

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated.

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

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, 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 therapeutic choices for low desire to a different group of females who may find help.

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

But it is not a simple solution. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT 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 reduced desire in women, although it is not officially approved for it.

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

“I am comfortable recommending flibanserin 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.

Additional suggestions for increasing libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “This involves understanding how your body works, your anatomy, 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.”