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

Prior to this week's decision, the medication, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

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

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

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

This medication was originally developed as an medication for depression but was deemed ineffective during early studies.

However, scientists noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before using the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

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

An gynecologist speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

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

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

“It's unclear if that has to do with the intricacies of the drug. If you take 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may find help.

“I believe it will serve this demographic 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 universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

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

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly dryness.

She hopes 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 treatment option.

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 lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending Addyi after discussing it 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:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“You have to take 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 anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”