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The federal agency expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to 65 years old.

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

This medication was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “logical” given the existing research.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of syncope. If a person has several drinks on a given day, the label advises not taking the pill 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 increased danger of fainting. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

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

Another doctor echoed uncertainty about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause experience a broad range of symptoms that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these issues is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

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

Testosterone is also sometimes prescribed off-label to address reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending Addyi 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 boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health 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 excited, and ultimately to have a climax of orgasm.”