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The Food and Drug Administration (FDA) widened the indication of a daily pill to treat low libido in females to cover women after menopause up to 65 years old.

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

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“I had few tools 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 group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the existing research.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the medication from which it draws its nickname.

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

However, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

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

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person has several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of fainting. But experts had concerns.

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

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

Another doctor expressed confusion 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 dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

“I do think it will benefit 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 interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

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

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

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

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

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

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

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

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

Additional suggestions for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” 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.”