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U.S. regulators expanded its approval of a once-a-day medication to manage low libido in females to now encompass postmenopausal women up to 65 years old.

Prior to this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional 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 menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the available data.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of syncope. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” 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 do think 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 specialists interviewed all agreed that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

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

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

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“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 alleviate the effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “That means understanding 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 climax of sexual pleasure.”