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U.S. regulators widened the indication of a once-a-day medication to manage low libido in females to cover women after menopause up to age 65.

Before the announcement, the pill, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in 2015, following a long and debated evaluation period.

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

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

The chief executive of the maker of flibanserin applauded the FDA’s decision to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” 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 magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The research, which were small in scale, showed no additional risk of fainting. 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 aren’t very long,” a public health expert stated.

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

“There have been side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. 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. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a new population 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 experts consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

Women after menopause experience a broad range of changes that can impact libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi 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 are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”