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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to 65 years old.

Before the recent news, the medication, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

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

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

However, scientists noted 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, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

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

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

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

Addressing Low Libido After Menopause

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

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

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

According to 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? 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 dryness.

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

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage 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 peak of orgasm.”