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U.S. regulators broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to age 65.

Before this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “understandable” 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 magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

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

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research examining the interaction. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

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

An gynecologist speculated that this may have been part of the cause why Addyi 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 things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. 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 clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of females who may find help.

“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 influenced by many factors.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of changes that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly vaginal dryness.

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

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

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

“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 psychosocial issues going on,” she said.

Additional suggestions for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “That means knowing 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 sexual pleasure.”