U.S. Food and Drug Administration Grants Approval to Flibanserin, a Libido-Enhancing Treatment for Women After Menopause
- The FDA expanded its approval of flibanserin, a pill to address low libido in women, to encompass postmenopausal women up to age 65.
- This decision will provide additional therapeutic avenues for older women, but health professionals advise that addressing HSDD requires a “whole body approach.”
- This drug presents potentially dangerous interactions with drinking that may cause fainting, so refraining from drinking is strongly advised.
U.S. regulators expanded its approval of a daily pill to treat low libido in females to include women after menopause up to age 65.
Prior to the announcement, the drug, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.
The drug was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.
The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.
Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.
The chief executive of the pharmaceutical company of Addyi praised the FDA’s action to expand the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.
Other OB-GYNs voiced approval for the decision.
“I had few tools for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”
A clinical professor told reporters that the decision was “understandable” given the existing research.
Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”
What is Flibanserin, the ‘Women's Desire Pill’?
Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.
This medication was initially researched as an antidepressant but was deemed ineffective during initial trials.
Nevertheless, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.
After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.
Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.
The label recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person has several drinks on a given day, the label advises skipping the dose entirely.
Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations.
“This research aren't 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 gynecologist suggested that this may have been part of the reason 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 alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.
Another doctor expressed uncertainty about why the broader approval was capped at 65 years of age.
“It's unclear if that has to do with the complexity 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 Diminished Sexual Desire in Postmenopausal Women
Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may find help.
“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 complex and multifaceted.
So addressing HSDD means considering everything from partnership issues to hormonal changes.
Women after menopause experience a broad range of changes that can impact libido. Symptoms of menopause encompass:
- sudden feelings of heat
- lack of natural lubrication
- discomfort with sex
- sleep disturbances
- urinary incontinence
According to one expert, managing these symptoms is often a initial approach toward sexual wellness.
“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.
The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly 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 view it as a treatment option.
Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it.
But besides medication, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.
“I am comfortable recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.
Additional recommendations for increasing libido include:
- improving sleep hygiene
- engaging in physical activity
- maintaining an active lifestyle
- applying over-the-counter personal lubricants
- practicing extended foreplay
- using vibrators or dilators
“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”
