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U.S. regulators broadened the authorized use of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to the age of sixty-five.

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

This medication was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was originally developed as an medication for depression but was deemed ineffective during early studies.

However, researchers observed positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance advises waiting at least two hours after drinking before taking the drug to reduce the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the maker to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of fainting. But experts had reservations.

“These studies don’t seem very convincing 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 postmenopausal women.

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

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. 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.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of women who may benefit.

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a broad range of changes that can impact libido. Symptoms of menopause include:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

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

“I would have no problem prescribing flibanserin after discussing it 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:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means knowing 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 peak of sexual pleasure.”