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U.S. regulators widened the indication of a oral treatment to manage low libido in females to now encompass women after menopause up to age 65.

Prior to the recent news, the medication, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the only FDA-approved oral medication 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 flibanserin praised the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the clinical evidence.

While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was first created as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking the drug to reduce the chance of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had reservations.

“This research aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert 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 adverse reactions like the syncopal episodes and dizziness especially in individuals 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 effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, flibanserin could still expand treatment options for low desire to a new population of women who may benefit.

“I do think 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 universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means considering everything from partnership issues to hormonal changes.

Women after menopause experience a broad range of changes that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view 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 besides medication, experts say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending Addyi 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 recommendations for increasing libido are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”