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U.S. regulators widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Prior to the recent news, the pill, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other specialists in female health voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the available data.

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

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

This medication was first created as an medication for depression but was considered unsuccessful during early studies.

However, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before taking the drug to minimize the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

So addressing HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can impact libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing libido are:

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

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means knowing how your body works, your physiology, 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.”