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The federal agency expanded its approval of a oral treatment to treat low libido in women to include postmenopausal women up to the age of sixty-five.

Before the recent news, the pill, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the decision.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant 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 approval was “logical” given the existing research.

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 magnitude of the enhancement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was initially researched as an antidepressant but was considered unsuccessful during initial trials.

However, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, 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 fainting. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

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

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons 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 confusion about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for HSDD to a different group of women who may benefit.

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

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

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

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“I would have no problem 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 recommendations for increasing libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “This involves knowing how your body works, your physiology, 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.”