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U.S. regulators widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

Before this week's decision, the pill, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

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

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude 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’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had concerns.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

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

“There have been adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may find help.

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

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido 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 changes that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these issues is often a initial approach toward improved intimacy.

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

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

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

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

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending 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.

Other recommendations for increasing libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”