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The Food and Drug Administration (FDA) widened the indication of a oral treatment to manage low libido in women to now encompass postmenopausal women up to 65 years old.

Before the recent news, the medication, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

The drug was first approved by the FDA in 2015, 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 raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

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.

The drug was first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the risk of fainting. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem 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 speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“Patients have experienced side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a different group of females who may find help.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “That means 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 orgasm.”