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U.S. regulators expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to age 65.

Prior to the announcement, the drug, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication 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 broaden the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs 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 OB-GYN. “Getting the FDA clearance for this group of women could be significant to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the clinical evidence.

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during initial trials.

However, scientists noted positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

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

The label advises allowing a two-hour gap after drinking before using Addyi to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“This research aren't very convincing 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 suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

“I don’t know 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 clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a new population of females who may benefit.

“I believe it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

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

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

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

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

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

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

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

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