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The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to 65 years old.

Before this week's decision, the pill, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health expressed support for the decision.

“I had few tools for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “quite reasonable” given the available data.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

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

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals 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 uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD 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 health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

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

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes used without formal approval to treat low libido in females, although it is not indicated 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 am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage 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 aroused, and ultimately to have a peak of orgasm.”