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U.S. regulators expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65.

Before this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s action to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population 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 reporters that the decision was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for older females.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped at age 65.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. 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 Diminished Sexual Desire in Postmenopausal Women

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

“I do think it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females navigate a wide variety of changes that can affect libido. Menopausal symptoms include:

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

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

“If somebody came to me with concerns about desire, my initial inquiry 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 treat the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift 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 address reduced desire in females, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“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 psychosocial issues going on,” she said.

Other recommendations for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health 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 climax of sexual pleasure.”