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U.S. regulators broadened the authorized use of a oral treatment to treat low libido in women to include postmenopausal women up to age 65.

Prior to the announcement, the drug, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

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

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, 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 first created as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

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

Official guidance recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

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

“I don’t know 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of changes that can impact sexual desire. Symptoms of menopause include:

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

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” 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 “serious” warning on HRT will lead more females to feel less concerned about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem 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 libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “This involves 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 sexual pleasure.”