U.S. Food and Drug Administration Grants Approval to Addyi, a Libido-Enhancing Drug for Females Beyond Menopause

U.S. regulators widened the indication of a daily pill to manage low libido in females to now encompass postmenopausal women up to age 65.

Prior to the recent news, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, 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 approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

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

Other women’s health experts expressed support for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, 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 draws its nickname.

The drug was initially researched as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

Addyi carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of syncope. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

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

An gynecologist suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes 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 susceptible to things like that,” she said.

Another doctor expressed confusion 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 approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of females who may find help.

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a wide variety of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

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

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

But besides medication, experts say that lifestyle should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “That means knowing 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 peak of orgasm.”