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The federal agency broadened the authorized use of a oral treatment to address low libido in females to include postmenopausal women up to 65 years old.

Before this week's decision, the drug, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health were supportive for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the available data.

While in favor, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential 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 considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, 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 risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund further research investigating the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“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 public health expert stated.

An OB-GYN speculated that this may have been part of the reason why the drug 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 drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

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

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

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may benefit.

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can affect libido. Menopausal symptoms encompass:

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

According to one expert, treating these symptoms is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly vaginal dryness.

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

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem recommending 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 recommendations for boosting sexual desire include:

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

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “This involves knowing 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.”