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U.S. regulators widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to the age of sixty-five.

Before the recent news, the drug, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared 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 again in 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the maker of Addyi praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts expressed support for the decision.

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

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

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

What is Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

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

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

The label advises waiting at least two hours after consuming alcohol before taking the drug to reduce the risk of syncope. If a person consumes several drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had reservations.

“These studies aren't very convincing 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 originally approved for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, 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.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a wide variety of symptoms that can affect libido. Symptoms of menopause include:

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

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

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on 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.

Additional suggestions for increasing libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “This involves 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.”