U.S. regulators widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to the age of sixty-five.
Before the recent news, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.
This medication was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.
The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.
Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.
The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.
Additional women’s health experts voiced approval for the decision.
“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”
A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the available data.
Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”
Addyi, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.
The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.
However, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.
After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.
The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.
The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.
Claims about the interactions of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, showed no additional risk of fainting. But experts had reservations.
“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.
An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.
“There have been side effects like the syncopal episodes and dizziness 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 effects 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 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.
Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of women who may benefit.
“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 simple solution. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.
So treating low desire means considering everything from partnership issues to shifts in hormone levels.
Women after menopause experience a broad range of changes that can impact sexual desire. Menopausal symptoms include:
As noted by one expert, treating these issues is often a initial approach toward improved intimacy.
“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.
The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.
She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.
Testosterone is also sometimes prescribed off-label to address reduced desire in females, although it is not indicated for it.
But besides medication, experts say that lifestyle should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.
“I would have no problem prescribing 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.
Other suggestions for boosting sexual desire include:
“It requires an comprehensive, holistic strategy to sexual health and this life stage 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 sexual pleasure.”
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