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U.S. regulators broadened the authorized use of a once-a-day medication to manage low libido in females to cover women after menopause up to 65 years old.

Prior to this week's decision, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

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

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

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

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the clinical evidence.

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

Understanding Flibanserin, the ‘Female Viagra’?

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

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

However, researchers noted positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

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

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were small in scale, showed no increased danger of fainting. But experts had reservations.

“These studies aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

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

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

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

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options 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 consulted all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

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

“I am comfortable prescribing flibanserin 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.

Additional suggestions for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, 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 sexual pleasure.”