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U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to the age of sixty-five.

Prior to the recent news, the drug, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “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 issues with libido.”

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

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

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

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

Nevertheless, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were limited in size, showed no increased danger of syncope. But experts had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why the drug was not originally approved for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, 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.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a new population 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 simple solution. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a broad range of changes that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• 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: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice.

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

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“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.

Other recommendations for increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”