🔗 Share this article

The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

Before the recent news, the drug, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved 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 FDA expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the decision.

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

A clinical professor told reporters that the decision was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

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

The drug was originally developed as an medication for depression but was considered unsuccessful during initial trials.

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

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

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

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

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But experts had concerns.

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

An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, 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.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a new population of women who may find help.

“I believe it will benefit this population better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

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

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

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

Androgen therapy is also occasionally used without formal approval to treat reduced desire in women, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“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 emotional and relational factors going on,” she said.

Additional recommendations for increasing libido are:

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

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “This involves understanding 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 peak of sexual pleasure.”