FDA Approves Flibanserin, a Libido-Enhancing Medication for Women After Menopause

The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Before this week's decision, the pill, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, 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 two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other women’s health experts voiced approval for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the clinical evidence.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was found to be lacking during initial trials.

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

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance advises waiting at least two hours after drinking before using Addyi to minimize the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. 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 beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested 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 syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a different group of women who may find help.

“I believe it will benefit this demographic 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 interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

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

Testosterone is also occasionally used without formal approval to treat reduced desire in women, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be factored in. 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 advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for boosting sexual desire include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a climax of orgasm.”