FDA Grants Approval to Addyi, a Desire-Boosting Treatment for Females Beyond Menopause

U.S. regulators widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to the age of sixty-five.

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

Flibanserin was initially cleared 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 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs 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 obstetrician-gynecologist. “Securing the FDA approval for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the enhancement is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

However, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the risk of syncope. If a person has several drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the combination. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had reservations.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire 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 believe it will serve 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 complex and multifaceted.

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

Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly dryness.

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

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

But besides medication, experts say that personal habits should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing libido include:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “That means knowing how your body works, your physiology, 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.”