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The federal agency expanded its approval of a once-a-day medication to manage low libido in women to cover women after menopause up to age 65.

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

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the benefit 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 “female Viagra,” has little in common with the drug from which it draws its nickname.

The drug was first created as an antidepressant but was deemed ineffective during early studies.

However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research 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.

The label advises waiting at least two hours after drinking before taking Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“These studies aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more sensitive 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. Reviewing a list of the instructions and restrictions, 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.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a different group of females who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward improved intimacy.

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

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

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

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

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

“I would have no problem recommending 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 suggestions for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause 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 excited, and ultimately to have a climax of sexual pleasure.”