FDA Grants Approval to Flibanserin, a Desire-Boosting Drug for Postmenopausal

U.S. regulators expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Prior to the recent news, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional OB-GYNs expressed support for the decision.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the existing research.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

This medication was first created as an antidepressant but was found to be lacking during early studies.

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

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

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

Official guidance recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of syncope. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had reservations.

“These studies don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped 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 dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options 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 medical problems,” said an OB-GYN.

But it is not a simple solution. In fact, the experts consulted all agreed that the female libido is influenced by many factors.

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

Women after menopause experience a broad range of changes that can affect libido. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“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 options to treat the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

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

Additional suggestions for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” 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 excited, and ultimately to have a peak of orgasm.”