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The federal agency expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old.

Before this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial review process.

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

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

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

Other women’s health experts expressed support for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

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

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

However, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

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

The label recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no increased danger 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 aren’t very long,” a health research president stated.

An gynecologist suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

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

Another doctor echoed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. If you take 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.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a new population of women who may benefit.

“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 magic bullet. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted.

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

Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

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

But besides medication, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

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

Other recommendations for boosting libido are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “This involves understanding how your body works, your anatomy, 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 orgasm.”