A trial drug alleviated hot flashes and enhanced sleep quality in menopausal women, sans the employment of hormones.
The drug titled elinzanetant performs its task by obstructing the brain chemicals responsible for experiencing hot flashes and night sweats, often referred to as vasomotor symptoms, in women who experience a decrease in estrogen and progesterone production from their ovaries, a stage in life known as menopause. Typically, menopause occurs in women between their 40s and 50s.
Last year, the Food and Drug Administration approved a similar drug named fezolinetant, sold under the brand name Veozah. These drugs provide fresh alternatives for women who are transitioning through a period in their lives, characterized by their bodies adapting to a new hormonal norm. This phase can induce several symptoms, including mood swings, memory lapses, sexual desire changes, and insomnia.
For some women, these symptoms are merely bothersome and do not disrupt their daily routines. However, for others, they can be significantly debilitating. Consequently, many physicians refrain from administering hormone replacement therapy due to the potential risks of stroke, cancer, and heart disease.
"Very few women receive any sort of assistance," highlighted Dr. Stephanie Faubion, director of the Mayo Clinic Center for Women's Health.
During the 1990s, about 40% of postmenopausal women relied on hormone replacement therapy (HRT). However, after a major government study revealed an increased risk of heart disease and cancer associated with HRT use, the use of hormones for menopausal symptoms dropped to roughly 4%, according to Faubion in a commentary on the studies.
Subsequent studies, including several new analyses of the data from the government trial, have demonstrated that HRT does not pose heightened health risks towards women when used near menopause and within a limited duration. Nevertheless, many doctors remain hesitant.
Furthermore, hormone-sensitive cancer survivors, such as certain breast cancers, cannot undergo HRT for menopausal relief. Consequently, these new non-hormonal drugs serve as advantageous alternatives, as Faubion, who was not involved in the new studies, notes. Veozah, a drug approved earlier, is, however, expensive, with a monthly list price of $550. Many insurance companies are reluctant to cover it. Bayer, the company that manufactures elinzanetant, has not disclosed its intended price for the drug.
Faubion has attempted to prescribe Veozah for a few patients, but their insurance companies required them to attempt at least two other, less expensive medications before approving coverage for the drug.
"They have to jump through hoops. And I have prescribed it before," Faubion said. She's unsure if her patients ever received the Veozah prescription or if they gave up before obtaining it.
Both fezolinetant and elinzanetant represent pioneering drugs that leverage a recently unfolded brain pathway to control hot flashes.
As estrogen production decreases in menopause, hypothalamus nerves – a minuscule region in the brain that regulates the body's thermostat, among other functions – become overactive and produce an overabundance of chemical signals called neurokinins. These new drugs obstruct the access points on cells where specific neurokinins dock, thereby reducing their capacity to stimulate the brain to cause hot flashes.
"These neurons are intriguing because they are also connected to mood, sleep, and appetite. And we know that this is a broad assortment of what many women experience in midlife – hot flashes, terrible moods, difficulty sleeping, and weight gain," Faubion explained. It remains unclear if targeting these neurons can alleviate concerns beyond hot flashes.
Hot flashes essentially manifest as a sudden sensation of severe heat, often centering around the face, chest, and head. Intense sweating and flushing can also accompany this sensation and persist for several minutes. When they occur at night, they are referred to as night sweats. Women in menopause may encounter hot flashes occasionally or frequently, which can significantly disrupt life.
The approximately 400 women enrolled in each of two related studies published Thursday in JAMA, experienced moderate to severe symptoms, characterized as having more than 50 hot flashes per week and an average of 14 to 16 daily.
In both trials, researchers administered the experimental drug to half of the women, while the other half took a placebo without any therapeutic effect. Neither the researchers nor the women were aware of who received the drug or the placebo. The women maintained daily diaries to monitor their symptoms. After four weeks, women taking elinzanetant reported approximately eight fewer hot flashes each day – nearly half the number they reported initially. In contrast, women taking the placebo reported about four fewer hot flashes per day, a reduction of approximately one-third. The disparity was statistically significant, implying it was unlikely due to chance. After 12 weeks, women taking elinzanetant reported an average of ten fewer hot flashes daily compared to an average change of roughly seven hot flashes daily in the placebo group. Women taking the drug also noted that their hot flashes were less intense and that they were sleeping better.
After concluding the 26-week-long study, over 80% of the participating females using elinzanetant reported a minimal 50% decrease in their frequent hot flashes. The findings from both studies showed striking similarities, bolstering the researchers' confidence in their results.
The majority of women using the drug experienced common side effects such as headaches and tiredness.
Notably, in a recent announcement, Bayer revealed that it had officially submitted the findings of the study to the FDA for authorization.
Faubion expressed optimism, stating, "It appears to be a highly promising medication." However, the level of accessibility remains uncertain.
"More alternatives for women are undeniably beneficial," Faubion concluded.
These new non-hormonal drugs, like elinzanetant, can significantly improve the quality of life for women experiencing debilitating menopausal symptoms by reducing the frequency and intensity of hot flashes. Maintaining good health is essential for every individual, and these drugs could potentially help many women manage their symptoms without the associated risks of hormone replacement therapy.
