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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 postmenopausal women up to 65 years old.

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

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious review process.

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

Now, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the available data.

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 enhancement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was originally developed as an medication for depression but was deemed ineffective during early studies.

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

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the maker to fund further research investigating the combination. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

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

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“It's unclear 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 cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

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

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

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause encompass:

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

As noted by one expert, treating these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

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

Other suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding 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 sexual pleasure.”