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U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to 65 years old.

Prior to the recent news, the drug, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “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 deemed ineffective during initial trials.

Nevertheless, scientists 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 cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

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

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had concerns.

“These studies aren't 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 OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty 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 dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of females who may find help.

“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 quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these issues is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness.

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

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

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido 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 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
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in later life,” said an expert. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”