🔗 Share this article

U.S. regulators expanded its approval of a daily pill to address low libido in women to cover women after menopause up to age 65.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “understandable” given the clinical evidence.

While in favor, the expert was measured in her assessment: “The studies 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 every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was originally developed as an medication for depression but was deemed ineffective during early studies.

Nevertheless, researchers noted positive changes in measures of libido and arousal 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 HSDD, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance recommends allowing a two-hour gap after drinking before taking the drug to reduce the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at age 65.

“It's unclear 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 cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of women who may find help.

“I believe 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 experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, experts 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 flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “This involves knowing how your body works, your physiology, 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.”