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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to manage low libido in women to cover women after menopause up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

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

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was first created as an medication for depression but was deemed ineffective during initial trials.

However, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

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

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund further research examining the interaction. The studies, which were small in scale, showed no additional risk of syncope. But experts had reservations.

“This research don’t seem very convincing 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 OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the fainting spells and lightheadedness 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 uncertainty about why the broader approval was limited at age 65.

“It's unclear 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 cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population of women 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 simple solution. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can affect libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, treating these issues is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Testosterone is also sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means 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 orgasm.”