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U.S. regulators broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional women’s health experts were supportive for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important 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 reporters that the approval was “understandable” given the clinical evidence.

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

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

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

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to reduce the chance of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The studies, which were limited in size, showed no additional risk of syncope. But experts had concerns.

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

An gynecologist speculated that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a different group of women who may find help.

“I do think it will benefit this population 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 all agreed that the female libido is influenced by many factors.

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

Postmenopausal females navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

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

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

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause 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 aroused, and ultimately to have a climax of sexual pleasure.”