FDA Clears Addyi, a Desire-Boosting Treatment for Postmenopausal

The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Before the announcement, the drug, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a long and debated review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive 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 obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not substantial. Is it worthwhile 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 little in common with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using the drug to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies 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 gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take 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 clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices 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 health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the experts interviewed all agreed that the female libido is influenced by many factors.

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

Postmenopausal females navigate a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me 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 options to treat 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 concerned about it and to consider it as a viable choice.

Testosterone is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means understanding 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 peak of sexual pleasure.”