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U.S. regulators widened the indication of a oral treatment to address low libido in women to now encompass women after menopause up to 65 years old.

Before the announcement, the drug, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on 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 approval for this group of women could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was first created as an medication for depression but was deemed ineffective during early studies.

However, researchers observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund additional studies examining the combination. The research, which were small in scale, showed no additional risk of fainting. But experts had reservations.

“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 OB-GYN suggested that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

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

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, 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.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a different group of females who may find help.

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

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

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

“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 symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Testosterone is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

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

Other recommendations for increasing libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

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