A new era in menopause treatment is on the horizon. This week, pharmaceutical company Bayer announced the results of two successful Phase 3 trials testing the experimental drug elinzanetant as a treatment for hot flashes. The drug is now poised to become the world’s first non-hormonal drug to be approved.
Hot sweats and night sweats A common symptom of menopause, affecting about 80% of women during their lifetime. Hot flashes, formally known as vasomotor symptoms, are characterized by sudden feelings of warmth, flushing, and sweating, usually around the face, neck, and chest (night sweats are similar, but occur at night and while you sleep). These episodes can be very uncomfortable, and in more severe cases, they are thought to increase the risk of sleep deprivation and depression. Hot flashes diminish over time, but often last at least two years, with some women experiencing them for more than 10 years. Mayo Clinic.
Historically, hot flashes have been effectively treated with hormone therapy, which aims to replace the estrogen and progesterone levels that decline with menopause. However, starting in the late 1990s, large-scale trials began to show that hormone therapy could potentially increase the risk of other health problems, including heart disease, breast cancer, and stroke, in postmenopausal women. As a result, treatment was soon drastically and consistently reduced. Subsequent studies and recent analyses Some of the data suggests that these risks may be overstated and can be safely mitigated. Organizations such as the North American Menopause Society Current status For most women, this means that the benefits of hormone therapy for hot flashes outweigh the potential harms if they begin treatment before age 60 and/or within 10 years of their last menstrual period. However, hormone therapy is much less popular than it used to be, and some women, such as those with a history of breast cancer, are at higher risk for complications from hormone therapy.
Women who don’t want to or can’t use hormones for hot flashes have had limited other options, such as low doses of certain SSRIs, until now. But in the early 2010s, scientists finally began to unravel some of the mechanisms underlying hot flashes. They discovered that a group of neurons that produce kisspeptin, neurokinin B (NKB), and dynorphin (called KNDy neurons) play a key role in triggering hot flashes associated with low estrogen levels. Later studies found that blocking the activity of some receptors in these cells could safely reduce hot flashes. And in May 2023, the Food and Drug Administration approved a drug called estrogen-based … Approved Astellas Pharma’s fezolinetant is the first drug to treat hot flashes by blocking one of these receptors, NK3.
Bayer’s elinzanetant blocks both NK3 and NK1 receptors, a dual-action design that scientists hoped would reduce hot flashes as well as sleep problems associated with menopause. In the largest Phase 3 trial of the drug, Posted Thursday Diary JamaThat hope appears to have been confirmed.
The studies involved more than 700 women in their 40s and 50s who had been diagnosed with moderate to severe hot flashes and were randomly assigned to receive either elinzanetant or a placebo. In both trials, researchers found that women who took elinzanetant (a once-daily pill) had a significant reduction in hot flashes compared to the control group. After 26 weeks of study, more than 80% of the women taking the drug had a greater than 50% reduction in symptoms, including those who switched to the drug at week 12. The participants also reported less sleep disturbance and a greater increase in menopause-related quality of life than women taking the placebo. Elinzanetant also appeared to be safe, and the most common side effects in people taking the drug (compared to placebo) were headache and fatigue.
“Elinzanetant has the potential to provide a well-tolerated and effective non-hormonal treatment option to address the unmet health needs of many moderate to severe menopausal individuals. [hot flashes]Researchers said Jama It was written in the newspaper.
These results follow equally promising results found in the company’s other phase 3 trial of elinzanetant. announce In early March, the company now plans to submit data from three studies to regulators to seek approval for the drug as a treatment for moderate to severe hot flashes. Barring any major surprises, approval is certain to follow.
As important as the launch of these drugs is, there is also the thorny issue of cost. Fezolinetant currently costs about $550 per month, Limited coverage According to Forbes, for now. These drugs could eventually be widely available, especially as more come onto the market, but for now, many eligible patients are likely unable to afford them.
