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The federal agency widened the indication 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 medication, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

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

Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs expressed support for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was deemed ineffective during early studies.

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

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, 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 fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

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

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

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

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

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

“It's unclear if that has to do with the complexity of the drug. 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 After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a different group of women who may benefit.

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females experience a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these symptoms is often a initial approach 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 recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a viable choice.

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

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable 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 sexual desire are:

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

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