FDA Approves Addyi, a Libido-Enhancing Medication for Females Beyond Menopause

The Food and Drug Administration (FDA) widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65.

Prior to the recent news, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

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

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “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 considered unsuccessful during initial trials.

However, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

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

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person consumes several drinks on a given day, the label advises skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research don’t seem 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 speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“There have been side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at 65 years of age.

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

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a new population of females who may find help.

“I do think it will benefit this population 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 women's sexual desire is complex and multifaceted.

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

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

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, treating these issues is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry 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 alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending 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.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”