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The federal agency widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, following a long and debated review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of Addyi praised the FDA’s action to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the existing research.

While in favor, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was first created as an antidepressant but was deemed ineffective during early studies.

However, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

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

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking Addyi to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, showed no additional risk of syncope. But experts had reservations.

“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 health research president stated.

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

“Patients have experienced adverse reactions like the fainting spells 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 susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a different group of women who may benefit.

“I believe it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a broad range of symptoms that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward improved intimacy.

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

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

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

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

But in addition to drugs, experts say that personal habits should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “This involves knowing 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 peak of orgasm.”