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The federal agency expanded its approval of a oral treatment to treat low libido in females to include postmenopausal women up to age 65.

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

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin praised the FDA’s action to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Other women’s health experts expressed support for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

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

However, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of fainting. If a person has several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals 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 echoed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. 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.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

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

As noted by one expert, managing these symptoms is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing 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.

Additional recommendations for boosting libido include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves 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.”