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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to address low libido in women to now encompass postmenopausal women up to 65 years old.

Before this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

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

Additional women’s health experts expressed support for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” 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 enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the available data.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

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

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

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

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

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

The label advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, showed no additional risk of syncope. But experts had concerns.

“These studies don’t seem 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 reason why the drug was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

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

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

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

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

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.

“When a patient presents 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 systemic hormone therapy as treatments to treat the effects of menopause, particularly vaginal dryness.

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

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

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

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

Other suggestions for boosting libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”