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U.S. regulators expanded its approval of a daily pill to address low libido in females to cover postmenopausal women up to age 65.

Before the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

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

Other OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to address postmenopausal women 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 “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

The drug was originally developed as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

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

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking the drug to minimize the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert 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 fainting spells and dizziness especially in persons who have had an alcoholic beverage 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 limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. 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 prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a different group of females who may benefit.

“I do think it will benefit 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 interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

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

But besides medication, experts say that lifestyle should also be considered. Conversations about libido 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 advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an expert. “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 orgasm.”