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The federal agency broadened the authorized use of a once-a-day medication to manage low libido in women to cover postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional 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 menopausal,” 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 enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the improvement is not dramatic. 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 often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was initially researched as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers noted positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of fainting. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

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

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

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the complexity 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 prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may benefit.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

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

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

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

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

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions 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 encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or vaginal dilators

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