🔗 Share this article

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s action to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to help 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 news outlets that the approval was “logical” given the available data.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was originally developed as an antidepressant but was considered unsuccessful during early studies.

However, scientists noted positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

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

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

The label advises waiting at least two hours after drinking before taking Addyi to minimize the risk of fainting. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” 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 postmenopausal women.

“There have been adverse reactions like the syncopal episodes 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 expressed uncertainty about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

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

But it is not a magic bullet. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of changes that can impact libido. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the regulatory decision to lift of its “black box” warning on HRT 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 females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable 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.

Other suggestions for increasing libido include:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “That means knowing 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 peak of orgasm.”