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U.S. regulators broadened the authorized use of a once-a-day medication to address low libido in females to include women after menopause up to age 65.

Before the recent news, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected 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, 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 two thousand nineteen.

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

Other OB-GYNs expressed support for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “understandable” given the available data.

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

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

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But experts had reservations.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for older females.

“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 older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty 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 dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

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

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

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy 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 females to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin after having a conversation 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:

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

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an expert. “This involves knowing 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 climax of sexual pleasure.”