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U.S. regulators expanded its approval of a daily pill to treat low libido in women to include women after menopause up to 65 years old.

Before the announcement, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

The drug 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 distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s decision to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other OB-GYNs voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted improvements in aspects 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 cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person has several drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“These studies don’t seem very persuasive to me. They are a beginning, 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 Addyi 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 taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a new population of females who may benefit.

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

But it is not a magic bullet. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a broad range of changes that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“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 vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a viable choice.

Testosterone is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable 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 suggestions for boosting libido include:

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

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”