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U.S. regulators widened the indication of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Before the recent news, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Other specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to help women after menopause 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 approval was “logical” given the existing research.

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, 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 originally developed as an medication for depression but was deemed ineffective during early studies.

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

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for serious adverse reactions, 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 taking Addyi to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research examining the combination. The research, which were small in scale, showed no additional risk of fainting. But medical professionals had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed 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 easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD 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 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 complex and multifaceted.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

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

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

As noted by one expert, treating these issues is often a first step toward improved intimacy.

“When a patient presents 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 treatments to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in women, although it is not officially approved for it.

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

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing libido include:

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

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing 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 climax of sexual pleasure.”