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The federal agency broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to 65 years old.

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

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. 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 “female Viagra,” has few similarities with the medication from which it draws its nickname.

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

However, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of syncope. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not initially cleared for older females.

“Patients have experienced 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 susceptible to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. 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 After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD 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 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 low desire means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause 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

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not officially approved for it.

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

“I would have no problem recommending Addyi 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.

Additional recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”