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U.S. regulators widened the indication of a oral treatment to treat low libido in females to cover postmenopausal women up to age 65.

Before the recent news, the medication, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

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

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a major advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, 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 treatment options for HSDD to a different group of females who may find help.

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

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

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for boosting libido are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “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 peak of sexual pleasure.”