U.S. Food and Drug Administration Clears Addyi, a Libido-Enhancing Treatment for Females Beyond Menopause

The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address low libido in females to include postmenopausal women up to the age of sixty-five.

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

This medication was first approved by the FDA in 2015, following a long and debated evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the maker of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other OB-GYNs expressed support for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” 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 experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not substantial. 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 often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

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

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

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

Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

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

An OB-GYN speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes 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 things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for low desire to a new population of women who may find help.

“I believe it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these issues 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 hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly dryness.

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

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

But in addition to drugs, experts say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”