The federal agency widened the indication of a oral treatment to manage low libido in females to include women after menopause up to 65 years old.
Prior to the recent news, the medication, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.
This medication was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.
Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.
Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.
The founder and CEO of the maker of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.
Additional OB-GYNs expressed support for the regulatory move.
“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval 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.
While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”
Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.
This medication was initially researched as an antidepressant but was considered unsuccessful during early studies.
However, scientists noted improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.
Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.
Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.
Official guidance recommends allowing a two-hour gap after drinking before taking the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.
Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, showed no increased danger of fainting. But experts had concerns.
“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.
An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.
“There have been side effects like the syncopal episodes and lightheadedness 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 things 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 intricacies of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.
Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may find help.
“I do think it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.
But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.
So treating HSDD means considering everything from partnership issues to hormonal changes.
Women after menopause experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause encompass:
According to one expert, managing these symptoms is often a initial approach toward improved intimacy.
“When a patient presents with concerns about desire, 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 FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.
Androgen therapy is also sometimes used without formal approval to treat reduced desire in women, although it is not officially approved for it.
But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.
“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.
Other recommendations for increasing sexual desire include:
“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “That means knowing 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.”
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