U.S. Food and Drug Administration Approves Addyi, a Libido-Enhancing Drug for Postmenopausal

The Food and Drug Administration (FDA) widened the indication of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to the age of sixty-five.

Before the recent news, the drug, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

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

Additional women’s health experts expressed support for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the clinical evidence.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was first created as an medication for depression 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, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

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

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, showed no additional risk 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 large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. 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 Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of females who may benefit.

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

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 low desire means considering everything from relationship dynamics to hormonal changes.

Women after menopause experience a wide variety of symptoms that can affect libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a first step toward sexual wellness.

“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 options to treat the effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing libido include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”