U.S. Food and Drug Administration Clears Flibanserin, a Desire-Boosting Medication for Females Beyond Menopause

The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Prior to the recent news, the pill, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

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

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

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

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

What is 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.

This medication was first created as an medication for depression but was considered unsuccessful during initial trials.

However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance advises waiting at least two hours after drinking before using Addyi to minimize the chance of fainting. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why the drug 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 taking the pill. When you get older, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD to a different group of women who may find help.

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

But it is not a simple solution. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

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

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

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

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

But in addition to drugs, doctors say that personal habits should also be factored in. Conversations about libido almost always start with 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 emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “This involves knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”