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The federal agency expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to 65 years old.

Prior to the announcement, the pill, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, 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 pharmaceutical company of flibanserin praised the FDA’s decision to expand the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial 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 news outlets that the approval was “logical” given the available data.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

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

The drug was originally developed as an medication for depression but was found to be lacking during initial trials.

Nevertheless, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

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

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after consuming alcohol before using the drug to minimize the chance of syncope. If a person has several drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause 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 drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a different group of women who may find help.

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

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a broad range of changes that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She hopes 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 consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”