U.S. Food and Drug Administration Approves Flibanserin, a Libido-Enhancing Medication for Postmenopausal

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Before the announcement, the pill, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population 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 news outlets 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 placebo, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an antidepressant but was considered unsuccessful during early studies.

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

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

The medication carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“These studies don’t seem very persuasive to me. They are a good start, 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 reason why Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped 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, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a different group of females 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 simple solution. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also occasionally prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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 boosting sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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 orgasm.”