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U.S. regulators broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

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

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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

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

The founder and CEO of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the available data.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the benefit is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

However, researchers observed positive changes in aspects 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 further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance 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 instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for older females.

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

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, 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 After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population of women who may find help.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to treat the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it.

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

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire include:

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

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”