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The federal agency widened the indication of a daily pill to treat low libido in females to cover postmenopausal women up to 65 years old.

Prior to the recent news, the pill, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a long and debated evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

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

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the clinical evidence.

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

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

However, researchers noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund further research examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN 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 dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies 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.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a new population of females who may benefit.

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

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“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 topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate 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 consider it as a viable choice.

Androgen therapy is also sometimes used without formal approval to address reduced desire in women, although it is not indicated for it.

But besides medication, experts say that personal habits should also be factored in. Conversations about libido almost always start with 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 emotional and relational factors going on,” she said.

Additional suggestions for boosting libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “That means understanding 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.”