FDA Approves Flibanserin, a Libido-Enhancing Treatment for Females Beyond Menopause

The federal agency broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Prior to the announcement, the pill, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a long and debated review process.

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

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

The founder and CEO of the maker of flibanserin applauded the FDA’s action to expand the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

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

Nevertheless, researchers noted improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of fainting. If a person has several drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“These studies aren't 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 suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of women who may find help.

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

But it is not a quick fix. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• 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 sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

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

But in addition to drugs, experts say that personal habits should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire are:

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

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”