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The federal agency expanded its approval of a oral treatment to manage low libido in females to now encompass women after menopause up to 65 years old.

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized 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 Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

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

Understanding Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has few similarities 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.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

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

The medication carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

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

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund additional studies investigating the combination. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons 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 broader approval was capped at 65 years of age.

“I don’t know 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 easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may find help.

“I do think it will benefit 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 all agreed that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a wide variety of changes that can impact libido. Symptoms of menopause encompass:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

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

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about libido 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 psychosocial issues going on,” she said.

Other recommendations for increasing libido include:

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

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, 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.”