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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to treat low libido in females to cover women after menopause up to the age of sixty-five.

Prior to the recent news, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s decision to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial 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 decision was “understandable” given the available data.

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has little in common with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

However, researchers observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

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

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

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects 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 drug. If you take 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 prescribing,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of women who may find help.

“I believe it will benefit 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 specialists interviewed all agreed that the female libido is complex and multifaceted.

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a broad range of symptoms that can impact libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem prescribing 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.

Other recommendations for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” 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 peak of orgasm.”