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U.S. regulators expanded its approval of a daily pill to manage low libido in females to include women after menopause up to 65 years old.

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

The drug was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of Addyi applauded the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

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

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be crucial 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 news outlets that the approval was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Women's Desire Pill’?

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

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

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

The label recommends allowing a two-hour gap after drinking before taking Addyi to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, demonstrated no increased danger of fainting. But experts had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very big 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 initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies 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 easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may benefit.

“I believe it will serve this population better as long as they have no other medical problems,” 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 addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly dryness.

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

Androgen therapy is also sometimes used without formal approval 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 relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting sexual desire include:

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

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”