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U.S. regulators expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to the age of sixty-five.

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

The drug was originally authorized by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the available data.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists observed positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before using the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, showed no additional risk of syncope. But experts had concerns.

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for older females.

“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 more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“It's unclear if that has to do with the complexity 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 clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population 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 magic bullet. In fact, the experts consulted all agreed that the female libido is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• 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? Is intercourse painful?” she said.

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

She expressed hope 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 view it as a viable choice.

Testosterone is also sometimes prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable prescribing flibanserin after having a conversation 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 boosting libido include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “This involves understanding how your body works, your anatomy, 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 sexual pleasure.”