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The federal agency widened the indication of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Prior to the recent news, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the clinical evidence.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

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

However, researchers noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The studies, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns.

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

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

“There have been side effects like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. 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

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a different group of females who may benefit.

“I believe it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause experience a wide variety of changes that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also occasionally prescribed off-label to treat low libido in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

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

Other suggestions for boosting libido include:

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

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an expert. “This involves understanding 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.”