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U.S. regulators widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to the age of sixty-five.

Prior to the recent news, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Additional specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was considered unsuccessful during initial trials.

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

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

The label recommends allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were small in scale, showed no increased danger of fainting. But experts had concerns.

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

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been 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 things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. If you take 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 prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a different group of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a broad range of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating 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 recommended both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women 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 low libido in females, although it is not officially approved for it.

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

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido are:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”