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U.S. regulators broadened the authorized use of a oral treatment to treat low libido in females to include women after menopause up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

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

Additional specialists in female health voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to help postmenopausal women 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 available data.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was found to be lacking during early studies.

However, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before using Addyi to minimize the risk of fainting. If a person consumes several drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“These studies don’t seem very convincing 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 speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. 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 complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

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

“I do think 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 influenced by many factors.

So addressing HSDD means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• 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 first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

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

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not indicated for it.

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

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also advise 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
• practicing extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “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 peak of orgasm.”