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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Prior to the recent news, the drug, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug 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 both cases, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of flibanserin commended the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Other women’s health experts expressed support for the regulatory move.

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

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the clinical evidence.

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

Understanding Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, researchers observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells and lightheadedness 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 broader approval 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, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of females who may benefit.

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

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

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope 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 view it as a viable choice.

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

But in addition to drugs, 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 recommending flibanserin 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 suggestions for boosting sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”