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U.S. regulators expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the existing research.

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

Understanding Flibanserin, the ‘Female Viagra’?

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

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the interaction. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for older females.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“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, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for low desire to a new population of women who may find help.

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a viable choice.

Testosterone is also occasionally prescribed off-label to address reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “This involves knowing how your body works, your anatomy, 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.”