FDA Clears Flibanserin, a Desire-Boosting Drug for Women After Menopause
- The FDA expanded its approval of flibanserin, a oral medication to treat low libido in women, to include postmenopausal women up to age 65.
- This decision will open up fresh choices for this demographic, but specialists warn that treating low libido requires a “comprehensive strategy.”
- This drug presents serious risks with alcohol that may result in loss of consciousness, so refraining from drinking is strongly advised.
U.S. regulators broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five.
Prior to the announcement, the pill, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.
Flibanserin was first approved by the FDA in two thousand fifteen, following a lengthy and contentious review process.
Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.
Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.
The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.
Other OB-GYNs expressed support for the regulatory move.
“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing 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 problems regarding libido.”
A clinical professor told news outlets that the approval was “quite reasonable” given the clinical evidence.
While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”
What is Addyi, the ‘Women's Desire Pill’?
Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.
This medication was initially researched as an antidepressant but was found to be lacking during initial trials.
However, researchers noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.
Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.
The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.
The label advises waiting at least two hours after consuming alcohol before taking the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.
Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns.
“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.
An gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for older females.
“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons 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 broader approval was capped at 65 years of age.
“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.
Treating Diminished Sexual Desire in Postmenopausal Women
Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of women who may benefit.
“I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.
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 low desire means engaging with everything from partnership issues to shifts in hormone levels.
Women after menopause navigate a broad range of changes that can affect sexual desire. Symptoms of menopause encompass:
- hot flashes
- vaginal dryness
- discomfort with sex
- insomnia
- urinary incontinence
As noted by one expert, managing these symptoms is often a first step toward sexual wellness.
“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.
The expert recommended both topical estrogen therapy and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.
She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice.
Testosterone is also sometimes prescribed off-label 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 begin by focusing on relationships and intimacy.
“I would have no problem prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.
Other suggestions for boosting libido include:
- getting more sleep
- engaging in physical activity
- maintaining an active lifestyle
- applying over-the-counter personal lubricants
- engaging in extended foreplay
- incorporating vibrators or vaginal dilators
“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “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 peak of orgasm.”