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The federal agency expanded its approval of a daily pill to address low libido in females to include postmenopausal women up to 65 years old.

Before the recent news, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was first approved by the FDA in 2015, following a long and debated review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s action to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the available data.

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

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance advises waiting at least two hours after drinking before using Addyi to reduce the risk 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 combining Addyi and alcohol eventually led the maker to fund further research investigating the interaction. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing 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 Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped 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 simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

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

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

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Women after menopause experience a broad range of changes that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, 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 treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view 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, doctors say that personal habits should also be factored in. Conversations about libido almost always start with relationships and intimacy.

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

Additional recommendations for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves 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 peak of sexual pleasure.”