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The federal agency expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

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

The founder and CEO of the maker of flibanserin praised the FDA’s decision 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.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed improvements in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the maker to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why the drug was not originally approved for older females.

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

Another doctor expressed confusion about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing 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 OB-GYN.

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

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a broad range of symptoms that can impact libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing 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 recommended both topical estrogen therapy and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for boosting libido are:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”