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The federal agency broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to age 65.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA cited issues about safety, 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 Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

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

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

A clinical professor told news outlets that the approval 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 magnitude of the enhancement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

The drug was originally developed as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

The medication 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 waiting at least two hours after drinking before taking Addyi 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.

Claims about the effects of mixing the drug with drinking eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had concerns.

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

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

“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 things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a different group of women who may find help.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females experience a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• 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 libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing flibanserin 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 suggestions for increasing libido include:

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

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”