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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 now encompass women after menopause up to age 65.

Prior to this week's decision, the drug, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a lengthy and contentious review process.

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

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

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other specialists in female health expressed support for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“This research don’t seem 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 reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at 65 years of age.

“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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these symptoms is often a first step toward sexual wellness.

“If somebody came to me with libido issues, 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 symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “black box” 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 sometimes prescribed off-label 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 factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

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

Other suggestions for increasing libido are:

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

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “That means knowing 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 climax of sexual pleasure.”