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The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to manage low libido in females to cover women after menopause up to 65 years old.

Prior to this week's decision, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of flibanserin praised the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

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

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was originally developed as an medication for depression but was deemed ineffective during initial trials.

However, scientists noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

“These studies 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 OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

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

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

“I don’t know if that has to do with the intricacies 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 prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for HSDD to a different group of females who may find help.

“I do think it will benefit this demographic 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 all agreed that the female libido is complex and multifaceted.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a broad range of symptoms that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a initial approach toward sexual wellness.

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable 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 recommendations for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “This involves 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.”