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

Before the recent news, the drug, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

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

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

Other specialists in female health expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was initially researched as an antidepressant but was deemed ineffective during initial trials.

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

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

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

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

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

An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

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

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a different group of females who may find help.

“I believe it will serve this population 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 consulted universally acknowledged that the female libido is influenced by many factors.

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

Postmenopausal females navigate a broad range of changes that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

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

“If somebody came to me 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 options to treat the effects of menopause, particularly dryness.

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

Androgen therapy is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

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

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexual health and this life stage in later life,” 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 aroused, and ultimately to have a peak of orgasm.”