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U.S. regulators broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Prior to this week's decision, the medication, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in 2015, following a long and debated regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Additional women’s health experts expressed support for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

This medication was originally developed as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before taking the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“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 gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

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

Another doctor expressed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear 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 clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a different group of women who may find help.

“I do think it will serve 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 influenced by many factors.

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

Postmenopausal females experience a wide variety of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, treating these symptoms is often a initial approach toward improved intimacy.

“When a patient presents 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 options to alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” 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 occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

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

“I would have no problem prescribing Addyi 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 boosting libido include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves understanding 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 sexual pleasure.”