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

The Food and Drug Administration (FDA) widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Before this week's decision, the drug, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

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

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the available data.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

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

Nevertheless, scientists noted improvements in aspects of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a different group of females who may find help.

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

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

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

Postmenopausal females navigate a wide variety of changes that can affect libido. Symptoms of menopause include:

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

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

“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 treat the effects 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 viable choice.

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

But besides medication, experts say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing sexual desire 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 entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding 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 climax of sexual pleasure.”