U.S. Food and Drug Administration Grants Approval to Flibanserin, a Desire-Boosting Treatment for Postmenopausal

The federal agency expanded its approval of a once-a-day medication to treat low libido in females to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the pill, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s decision to expand the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

Other OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was found to be lacking during early studies.

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

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

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

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of syncope. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had reservations.

“These studies aren't very persuasive 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 suggested that this may have been part of the reason why Addyi was not initially cleared for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the complexity 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 clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a new population of women who may benefit.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of changes that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“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 systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

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

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

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means understanding how your body works, your physiology, 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 orgasm.”