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U.S. regulators broadened the authorized use of a oral treatment to treat low libido in women to now encompass women after menopause up to 65 years old.

Before the announcement, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health 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 OB-GYN. “Getting the FDA approval for this group of women could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the existing research.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after consuming alcohol before using the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, showed no additional risk of syncope. But experts had reservations.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“Patients have experienced adverse reactions like the fainting spells and lightheadedness 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.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, they are extensive. 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 Low Libido After Menopause

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

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

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not officially approved for it.

But besides medication, 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 Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire include:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “This involves understanding 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 peak of orgasm.”