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The federal agency widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Other OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “understandable” given the available data.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

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 recommends allowing a two-hour gap after consuming alcohol before taking the drug to reduce the chance of fainting. If a person has several drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not originally approved 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 sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand therapeutic choices for low desire to a different group of women who may benefit.

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

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females experience a broad range of symptoms that can impact libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

As noted by one expert, managing 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? Are you comfortable?” 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 FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”