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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65.

Prior to this week's decision, the drug, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of Addyi commended the FDA’s move to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding 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 inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

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

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” 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 older females.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion 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. If you take 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 clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for HSDD to a new population of females who may benefit.

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

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include:

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

As noted by one expert, treating these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

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

“I am comfortable prescribing Addyi 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.

Additional recommendations for boosting sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

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