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The federal agency expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to the age of sixty-five.

Before the recent news, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a long and debated evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Currently, 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 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “understandable” given the available data.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

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

The label recommends waiting at least two hours after drinking before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“This research aren't very persuasive to me. They are a good start, 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 cause why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells 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 sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a new population of females who may benefit.

“I believe it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

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

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

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

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

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

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

Testosterone is also sometimes used without formal approval to treat reduced desire in women, although it is not officially approved for it.

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

“I would have no problem prescribing 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
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” 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 aroused, and ultimately to have a peak of sexual pleasure.”