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

Prior to this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females.

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other women’s health experts were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

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

However, researchers observed positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin 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 side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. 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 After Menopause

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

“I do think 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 experts interviewed all agreed 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 broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

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

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

She expressed hope 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 consider it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in women, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and this life stage 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 peak of orgasm.”