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U.S. regulators broadened the authorized use of a daily pill to manage low libido in females to now encompass postmenopausal women up to the age of sixty-five.

Before the announcement, the pill, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug 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 separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s action to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

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

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

However, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

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

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using the drug to minimize the chance of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, showed no increased danger of syncope. 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 are short-term,” a health research president stated.

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

“Patients have experienced 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 susceptible to effects 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 complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of females who may find help.

“I believe it will benefit 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 consulted universally acknowledged that the female libido is influenced by many factors.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

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

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

“I would have no problem prescribing flibanserin 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 boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means knowing 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 sexual pleasure.”