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The federal agency expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to the age of sixty-five.

Prior to the recent news, the pill, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

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

Additional specialists in female health 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 menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to address women after menopause 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 “logical” given the available data.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

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

However, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after drinking before using Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The research, which were limited in size, showed no increased danger of syncope. But experts had reservations.

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

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may find help.

“I believe it will serve 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 all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

“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 systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

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

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable 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.

Other suggestions for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “This involves knowing 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 peak of orgasm.”