FDA Clears Addyi, a Libido-Enhancing Treatment for Postmenopausal

U.S. regulators widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to the age of sixty-five.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin 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 flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to recommend 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 significant to address 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 “understandable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was deemed ineffective during early studies.

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

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

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

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The studies, which were limited in size, showed no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

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

Another doctor echoed uncertainty about why the broader approval was limited at age 65.

“I don’t know 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 approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of women who may find help.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted 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 navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

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

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

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

Androgen therapy is also sometimes used without formal approval to address reduced desire in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy.

“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 psychosocial issues going on,” she said.

Additional recommendations for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means knowing how your body works, your physiology, 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.”