FDA Approves Flibanserin, a Desire-Boosting Drug for Postmenopausal

U.S. regulators broadened the authorized use of a oral treatment to treat low libido in females to cover postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the available data.

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

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

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

Nevertheless, researchers noted improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

The label advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance of fainting. If a person has several drinks on a given day, the label advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, showed no additional risk of syncope. But experts had reservations.

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

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been side effects like the fainting spells and dizziness especially in persons 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 confusion about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

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

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

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 addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach 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 suggested both topical estrogen therapy and systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

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

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

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing flibanserin 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 increasing sexual desire include:

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

“It requires an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”