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The federal agency widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

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

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women 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 clinical professor told reporters that the approval was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“These studies aren't very convincing 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 OB-GYN speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“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 sensitive to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions 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 different group of females who may find help.

“I believe it will benefit this demographic better as long as they have no other health issues,” said an specialist.

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

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

Postmenopausal females experience a broad range of changes that can impact sexual desire. Symptoms of menopause include:

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

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also sometimes prescribed off-label 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. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending 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 increasing libido are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, 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.”