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U.S. regulators broadened the authorized use of a oral treatment to address low libido in females to include women after menopause up to 65 years old.

Prior to this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a long and debated evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive 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 obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

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

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

Nevertheless, researchers noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

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

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

Official guidance advises 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 instructions recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

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

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for older females.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden treatment options for low desire to a different group of women who may benefit.

“I believe it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly dryness.

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

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

But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin after discussing it 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 increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” 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 climax of sexual pleasure.”