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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to 65 years old.

Before this week's decision, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Additional specialists in female health were supportive for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing 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 professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the clinical evidence.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding 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.

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research investigating the interaction. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had concerns.

“These studies aren't very convincing 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 OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and dizziness especially in persons 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 expressed uncertainty about why the broader approval 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 instructions and restrictions, 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 prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a different group of women who may benefit.

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

But it is not a simple solution. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to hormonal changes.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

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

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label 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. Conversations about sexual desire almost always start with relationships and intimacy.

“I am comfortable 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 recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “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 orgasm.”