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The federal agency expanded its approval of a daily pill to manage low libido in females to include postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a protracted and controversial review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

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

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

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

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

Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major advocacy campaign.

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 recommends allowing a two-hour gap after drinking before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

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

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

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand treatment options for HSDD to a different group of females who may benefit.

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

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

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

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“If somebody came to me with concerns about desire, my first question 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 symptoms of menopause, particularly vaginal dryness.

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

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable 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 include:

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

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “This involves understanding 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 orgasm.”