FDA Clears Flibanserin, a Libido-Enhancing Drug for Females Beyond Menopause

The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage low libido in women to cover postmenopausal women up to 65 years old.

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

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, 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 applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other women’s health experts voiced approval for the decision.

“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 clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

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

The drug was initially researched as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why Addyi was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

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

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

But it is not a magic bullet. In fact, the experts interviewed all agreed that the female libido is influenced by many factors.

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

Women after menopause experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these issues 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? Are you comfortable?” 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 hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “That means knowing 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 sexual pleasure.”