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The federal agency broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65.

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

Flibanserin was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

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

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

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

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

Official guidance advises waiting at least two hours after drinking before using the drug to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the maker to fund further research examining the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, 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 intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi 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 specialist.

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

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can affect libido. Menopausal symptoms encompass:

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

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly 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 low libido in females, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors 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
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “That means 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.”