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U.S. regulators expanded its approval of a once-a-day medication to address low libido in females to cover postmenopausal women up to 65 years old.

Before the announcement, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

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

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be significant to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

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

This medication was originally developed as an medication for depression but was deemed ineffective during initial trials.

However, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

Addyi carries a serious safety warning for severe side effects, 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 taking Addyi to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

“These studies don’t seem very persuasive 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 gynecologist suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

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

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for HSDD to a new population of females who may find help.

“I believe it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females 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 females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”