FDA Approves Addyi, a Desire-Boosting Medication for Women After Menopause

The federal agency expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the medication, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to help 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 “quite reasonable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a good start, 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 reason why Addyi was not initially cleared for older females.

“Patients have experienced adverse reactions 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 susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the medication. 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 simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a new population of women who may benefit.

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

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So treating low desire means engaging with everything from partnership issues to hormonal changes.

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

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to address low libido in females, 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 start with 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 emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”