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U.S. regulators expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

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

This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s action to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

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

However, scientists noted positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

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

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of fainting. If a person has several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were limited in size, showed no additional risk of fainting. But experts had concerns.

“This research don’t seem 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 suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. 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 in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a new population of females who may benefit.

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

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

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

Women after menopause experience a broad range of symptoms that can affect sexual desire. Symptoms of menopause encompass:

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

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

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to alleviate 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 women to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also sometimes used without formal approval 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. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable recommending Addyi 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.

Other recommendations for boosting libido include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”