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U.S. regulators expanded its approval of a oral treatment to treat low libido in women to include women after menopause up to 65 years old.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized 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 again in 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other women’s health experts voiced approval for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the enhancement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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 initially researched as an antidepressant but was deemed ineffective during early studies.

However, researchers observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before using Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The research, which were limited in size, showed no additional risk of fainting. 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 aren’t very long,” a health research president 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 individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the medication. Reviewing 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.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of women who may benefit.

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

But it is not a simple solution. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can affect libido. Menopausal symptoms encompass:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it.

But besides medication, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin 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.

Additional recommendations for increasing libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “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 climax of sexual pleasure.”