🔗 Share this article

U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to age 65.

Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

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

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has little in common with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was found to be lacking during early studies.

However, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after drinking before using the drug to reduce the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very convincing to me. They are a beginning, 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 cause why Addyi was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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 demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to hormonal changes.

Women after menopause experience a wide variety of symptoms that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing 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 recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

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

“I am comfortable prescribing flibanserin 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 suggestions for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage 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 peak of sexual pleasure.”