FDA Approves Flibanserin, a Desire-Boosting Treatment for Women After Menopause
- The FDA expanded its approval of flibanserin, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65.
- The regulatory green light will unlock new treatment options for older women, but specialists warn that addressing HSDD requires a “comprehensive strategy.”
- This drug presents potentially dangerous interactions with alcohol that may cause syncope, so avoiding alcoholic beverages is recommended.
U.S. regulators broadened the authorized use of a oral treatment to treat low libido in women to now encompass women after menopause up to age 65.
Before the recent news, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.
This medication was originally authorized by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.
The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.
Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.
The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.
Other women’s health experts expressed support for the regulatory move.
“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”
A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the clinical evidence.
While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”
What is Flibanserin, the ‘Female Viagra’?
Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.
The drug was first created as an medication for depression but was deemed ineffective during initial trials.
However, researchers observed 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, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.
Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.
Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.
Claims about the effects of combining Addyi and alcohol eventually led the maker to fund further research investigating the interaction. The research, which were small in scale, demonstrated 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 large-scale and certainly aren’t very long,” a public health expert stated.
An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.
“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an drink 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 confusion about why the expanded indication was limited at age 65.
“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.
Treating Low Libido in Postmenopausal Women
Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a new population of females who may benefit.
“I do think it will serve this population better as long as they have no other health issues,” said an OB-GYN.
But it is not a simple solution. In fact, the experts consulted all agreed that the female libido is influenced by many factors.
So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.
Postmenopausal females experience a wide variety of changes that can affect sexual desire. Symptoms of menopause include:
- sudden feelings of heat
- vaginal dryness
- discomfort with sex
- sleep disturbances
- urinary incontinence
As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.
“When a patient presents with libido issues, 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 alleviate the symptoms of menopause, particularly dryness.
She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a treatment option.
Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not officially approved for it.
But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.
“I would have no problem 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.
Other recommendations for increasing sexual desire include:
- improving sleep hygiene
- engaging in physical activity
- maintaining an active lifestyle
- applying over-the-counter personal lubricants
- practicing extended intimate stimulation
- using sexual wellness devices or dilators
“It requires an entire whole body approach to sexuality and this life stage in later life,” 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 excited, and ultimately to have a climax of orgasm.”