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U.S. regulators expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Before this week's decision, the medication, Addyi (flibanserin), was only approved to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations 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 as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin praised the FDA’s decision to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

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

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, 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.

However, scientists noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem 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 the drug was not originally approved for postmenopausal women.

“Patients have experienced 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 echoed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, 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 prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD 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 health issues,” said an OB-GYN.

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

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

Postmenopausal females navigate a broad range of symptoms that can impact libido. Menopausal symptoms 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 improved intimacy.

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

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly 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 treatment option.

Androgen therapy is also occasionally prescribed off-label to address low libido in females, although it is not indicated for it.

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

“I am comfortable recommending flibanserin 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.

Additional suggestions for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating 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. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”