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The Food and Drug Administration (FDA) widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

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

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

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

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

Other OB-GYNs expressed support 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 address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the existing research.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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.

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of syncope. If a person has several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had concerns.

“This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for low desire to a different group of females who may find help.

“I believe it will serve this demographic 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 interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing HSDD means engaging with 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
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects 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 concerned about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to treat reduced desire in females, 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 relationships and intimacy.

“I would have no problem 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.

Additional recommendations for boosting libido are:

• getting more sleep
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “This involves 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 peak of orgasm.”