FDA Approves Addyi, a Libido-Enhancing Treatment for Women After Menopause

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat low libido in females to now encompass postmenopausal women up to age 65.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

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

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her assessment: “Clinical trials 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 seeing a major effect?”

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

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

This medication was initially researched as an medication for depression but was deemed ineffective during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had reservations.

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

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

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage 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 expressed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for low desire to a different group of women who may find help.

“I do think it will serve this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“When a patient presents 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 hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal 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 consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval 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 considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“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.

Other suggestions for boosting libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “This involves 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.”