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The federal agency expanded its approval of a daily pill to address low libido in women to include postmenopausal women up to 65 years old.

Before the recent news, the drug, flibanserin (Addyi), was exclusively cleared to treat 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 regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s action to broaden the drug’s indication, 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 recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to address postmenopausal women 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 decision was “logical” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

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

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

The drug was first created as an medication for depression but was found to be lacking during initial trials.

Nevertheless, researchers observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were limited in size, showed no additional risk of syncope. But experts had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very big 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 originally approved for postmenopausal women.

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

Another doctor expressed uncertainty about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, they are extensive. 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 in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of women who may benefit.

“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 magic bullet. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing these issues is often a first step toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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 recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “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 peak of sexual pleasure.”