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The federal agency broadened the authorized use of a daily pill to treat low libido in females to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Now, 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 two thousand nineteen.

The founder and CEO of the maker of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs voiced approval for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval 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 degree of the improvement is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was found to be lacking during initial trials.

However, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before using the drug to minimize the risk of syncope. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the maker to fund further research investigating the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells 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 things like that,” she said.

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

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a wide variety of changes that can affect libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward sexual wellness.

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

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

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing libido include:

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

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “That means knowing 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 peak of orgasm.”