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The federal agency broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to 65 years old.

Before the recent news, the pill, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial 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.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address 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 “quite reasonable” given the available data.

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

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

However, scientists noted positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund additional studies examining the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

“These studies don’t seem very convincing 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 OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects 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 complexity of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of females who may benefit.

“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 quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Menopausal symptoms encompass:

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

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing 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 boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding 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 sexual pleasure.”