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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat low libido in women to now encompass postmenopausal women up to 65 years old.

Prior to the announcement, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s decision to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to help postmenopausal women who want to have 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 clinical evidence.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

However, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, demonstrated no increased danger of fainting. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” 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 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 things like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of females 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 quick fix. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to hormonal changes.

Women after menopause experience a broad range of changes that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

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

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

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

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “That means knowing 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 peak of orgasm.”