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The federal agency widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Before the announcement, the medication, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was first approved by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s action to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health voiced approval for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the existing research.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of syncope. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies examining the interaction. The studies, which were small in scale, showed no increased danger of fainting. But experts had concerns.

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

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

“Patients have experienced adverse reactions 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 capped at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population 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 specialist.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated 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 relationships and intimacy.

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

Additional recommendations for boosting sexual desire include:

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

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