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U.S. regulators broadened the authorized use of a daily pill to address low libido in females to include postmenopausal women up to age 65.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant 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 news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president 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 syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. 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 capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. 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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may find help.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

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

Postmenopausal females experience a wide variety of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to treat low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, 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 orgasm.”