FDA Grants Approval to Addyi, a Desire-Boosting Drug for Women After Menopause
- The agency widened the authorized use of flibanserin, a daily drug to address low libido in women, to encompass postmenopausal women up to age 65.
- The approval will open up fresh choices for this demographic, but specialists warn that addressing HSDD requires a “comprehensive strategy.”
- The medication carries potentially dangerous interactions with alcohol that may cause loss of consciousness, so avoiding alcoholic beverages is recommended.
U.S. regulators broadened the authorized use of a oral treatment to address low libido in women to cover women after menopause up to age 65.
Before the recent news, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.
This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.
Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.
Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.
The chief executive of the maker of flibanserin praised the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.
Other OB-GYNs expressed support for the regulatory move.
“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to help 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 approval was “logical” given the available data.
Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”
Understanding 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 first created as an medication for depression but was deemed ineffective during initial trials.
However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.
After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.
The medication carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.
The label recommends waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.
Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had reservations.
“This research aren't very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.
An OB-GYN suggested that this may have been part of the reason why the drug was not initially cleared for older females.
“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.
Another doctor expressed confusion about why the broader approval was limited 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, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.
Addressing Diminished Sexual Desire After Menopause
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 health issues,” said an OB-GYN.
But it is not a quick fix. In fact, the specialists consulted universally acknowledged 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 symptoms that can impact sexual desire. Menopausal symptoms include:
- hot flashes
- 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.
“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” 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 regulatory decision to lift of its “black box” 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 prescribed off-label to treat reduced desire in females, although it is not officially approved for it.
But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.
“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.
Other suggestions for boosting libido include:
- improving sleep hygiene
- engaging in physical activity
- maintaining an active lifestyle
- using over-the-counter personal lubricants
- practicing extended intimate stimulation
- using sexual wellness devices or vaginal 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 physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”
