🔗 Share this article

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65.

Before this week's decision, the pill, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

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

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

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

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

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

Nevertheless, scientists noted positive changes in aspects of libido and arousal and shifted focus 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 additional research and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

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

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a new population of women who may find help.

“I believe it will benefit this population better as long as they have no other medical problems,” said an specialist.

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

So treating low desire means engaging with everything from partnership issues to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Testosterone is also occasionally prescribed off-label to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem recommending flibanserin 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 sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an expert. “That means knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”