A woman experiencing hot flashes due to menopause (Photo by Pheelings media on Shutterstock)
CHARLOTTESVILLE, Va. — A new drug may finally make menopause a much more tolerable experience for many women who deal with hot flashes. Researchers found that taking the non-hormonal drug elinzanetant improved the quality of life of middle-aged women after 12 weeks, rapidly and significantly reducing the impact of hot flashes.
“The effectiveness for relief of hot flashes in highly symptomatic women along with improvements in sleep and mood across multiple trials and favorable safety profile of elinzanetant suggests it has potential as a non-estrogen treatment for women with bothersome menopausal symptoms,” says researcher JoAnn V. Pinkerton, MD, the University of Virginia Health System’s director of midlife health, in a media release.
Women going through menopause experience hot flashes because of a drop in estrogen levels. Hormone therapy is the usual treatment for dealing with hot flashes and other menopause symptoms, but it’s not a perfect solution. Some women cannot tolerate hormone therapy, experience side-effects that worsen their quality of life, or cannot undergo the therapy because they are taking other medications that could trigger harmful reactions to hormone treatments.
Elinzanetant stood out as a promising drug candidate because it contains no estrogen. Instead of elevating hormone levels that could cause off-target effects, the drug works by targeting two receptors in the brain known to contribute to hot flashes, night sweats, and mood swings. Two phase 3 clinical trials tested elinzanetant and found decreases in hot flash frequency and improved sleep quality. The full results are published in the Journal of the American Medical Association.
The OASIS 1 and 2 clinical trials randomly assigned postmenopausal women between the ages of 40 and 65 to receive either 120 mg of elinzanetant for 26 weeks or a placebo for 12 weeks and then elinzanetant for the remaining 14 weeks. All women reported having moderate to severe hot flashes before the start of the trials. Along with looking at the drug’s effectiveness in reducing hot flashes, sleep disruptions, and improving quality of life, the researchers looked at potential side-effects. In total, 309 women completed the OASIS 1 clinical trial, and 324 completed the OASIS 2 clinical trial.
The clinical trials showed significant decreases in hot flash frequency and severity within the first week of taking elinzanetant. After 12 weeks, women reported better sleep quality and menopausal-related quality of life. There were also no severe issues with taking the drug. The most common side-effects were mild headaches and fatigue.
The results showed elinzanetant is a safe and effective drug for managing hot flashes during menopause. With limited menopause treatments, elinzanetant opens up a whole new option for women who want a hormonal alternative to estrogen therapy.
The clinical trial data will help with elinzanetant gaining medical approval as a future menopause drug. However, there are some limitations to consider. Most of the results came from the subjective experiences of women taking the drug as data was collected through diaries or questionnaires. Second, the trial does not account for women who are perimenopausal and those experiencing hot flashes for different reasons, such as breast cancer or endocrine therapy. The next clinical trial, OASIS 4, will test elinzanetant among patients with breast cancer.
Paper Summary
Methodology
The OASIS 1 and 2 trials were large, randomized, double-blind studies conducted across multiple countries. Participants were postmenopausal women aged 40-65 experiencing at least 50 moderate to severe hot flashes per week. Half the women received 120 mg of elinzanetant daily, while the other half received a placebo for 12 weeks. After that, all participants took elinzanetant for another 14 weeks.
Researchers measured changes in hot flash frequency and severity using electronic diaries. They also assessed sleep quality and overall menopause-related quality of life through questionnaires. The study design ensured that neither the participants nor the researchers knew who was receiving the actual drug versus the placebo until after the study concluded.
Key Results
Elinzanetant significantly reduced the frequency and severity of hot flashes compared to placebo at both 4 and 12 weeks. Over 70% of women taking elinzanetant had at least a 50% reduction in hot flashes by week 12.
Sleep disturbances improved significantly with elinzanetant compared to placebo. Overall, measures of menopause-related quality of life showed greater improvement with elinzanetant than while taking a placebo.
The effects of elinzanetant were maintained through 26 weeks of treatment. The most common side-effects were headache and fatigue, which were generally mild.
Study Limitations
The study relied on self-reported outcomes, which can be subjective. There was also a notable placebo effect, which is common in vasomotor symptom studies.
Researchers note the participant pool was primarily White women, with limited representation of other racial and ethnic groups. The study also only included postmenopausal women, not those in perimenopause or with treatment-induced symptoms (e.g., from cancer therapies). Finally, participants weren’t required to have sleep disturbances to enroll, potentially limiting the assessment of elinzanetant’s effect on sleep.
Discussion & Takeaways
Elinzanetant appears to be an effective non-hormonal treatment for menopausal hot flashes. The drug not only reduces hot flashes but also improves sleep and overall quality of life. Its effects are rapid, with significant improvements seen as early as one week in some measures.
The safety profile seems favorable, with no serious liver or endometrial concerns noted. Elinzanetant could provide a new option for women who can’t or prefer not to use hormone therapy. However, more research is necessary on diverse populations and long-term effects.
Funding & Disclosures
The OASIS 1 and 2 trials were funded by Bayer, the pharmaceutical company developing elinzanetant. Many of the study authors reported receiving consulting fees, grants, or other forms of compensation from various pharmaceutical companies, including Bayer. These relationships were disclosed in the study publication to ensure transparency about potential conflicts of interest. It’s important to note that while industry funding doesn’t invalidate research, it’s a factor to consider when interpreting results.
