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U.S. regulators expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to age 65.

Before the announcement, the pill, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

This medication was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the available data.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

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

The drug was initially researched as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

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

The label recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, 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 reason why the drug was not initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

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

“I believe it will benefit 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 interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, managing these issues is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

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

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“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.

Additional recommendations for boosting libido are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “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 peak of orgasm.”