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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

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

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was originally developed as an medication for depression but was found to be lacking during initial trials.

Nevertheless, researchers noted positive changes 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 approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“These studies don’t seem very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

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

Another doctor expressed confusion 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 dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a new population of women who may benefit.

“I believe it will benefit 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 female libido is influenced by many factors.

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

Women after menopause experience a wide variety of changes that can affect libido. Menopausal symptoms encompass:

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

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also occasionally used without formal approval to address reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable 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.

Additional suggestions for increasing libido include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a peak of orgasm.”