U.S. Food and Drug Administration Grants Approval to Addyi, a Desire-Boosting Treatment for Females Beyond Menopause

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

Prior to this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two separate occasions, 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, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the existing research.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was deemed ineffective during early studies.

However, scientists observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were limited in size, demonstrated no increased danger of fainting. 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 health research president stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. Reviewing 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 clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

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

“I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of changes that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

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

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

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”