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The Food and Drug Administration (FDA) expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old.

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

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin praised 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 voiced approval 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 group of women could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was first created as an medication for depression but was found to be lacking during initial trials.

Nevertheless, researchers noted positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the maker to fund further research examining the combination. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved 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 more advanced in age, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

“I believe it will serve this population better as long as they have no other health issues,” said an specialist.

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

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem recommending Addyi 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.

Other recommendations for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “This involves 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 orgasm.”