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The federal agency widened the indication of a daily pill to address low libido in women to now encompass postmenopausal women up to age 65.

Before the recent news, the medication, Addyi (flibanserin), was only approved to treat low sexual desire in premenopausal females.

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 distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

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

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to address 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 news outlets that the approval was “quite reasonable” given the clinical evidence.

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

What is Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

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

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

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using Addyi to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

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

“These studies aren't very persuasive to me. They are a good start, 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 cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of females who may benefit.

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

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

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

Women after menopause navigate a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

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

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

But besides medication, experts say that personal habits should also be factored in. Discussions about sexual desire 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.

Additional recommendations for boosting sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” 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 aroused, and ultimately to have a climax of sexual pleasure.”