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U.S. regulators widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s action to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” 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 placebo, but the degree of the benefit is not dramatic. Does it justify taking a drug daily 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 medication from which it draws its nickname.

This medication was first created as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before taking the drug to minimize the risk of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

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

“This research don’t seem very persuasive 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 speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

“I don’t know 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 cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of women who may benefit.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

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

Women after menopause navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

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

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

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

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

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a treatment option.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire are:

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

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “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 excited, and ultimately to have a peak of sexual pleasure.”