ST. PAUL, Minn., Sept. 10 (UPI) -- German pharma giant Bayer this week published the full results of a major clinical study demonstrating the long-term safety and efficacy of its hot flash drug elinzanetant as it awaits delayed approval decisions by U.S. regulators.
The Phase 3 study's findings, released Monday in JAMA Internal Medicine, found that elinzanetant met goals set for effectiveness in relieving moderate-to-severe "vasomotor symptoms," or VMS, such as hot flashes and sleep disruptions over a period of 52 weeks -- doubling the timeline established in earlier studies.
The researchers also found the drug was safe after participants took it for a year, bolstering widespread hopes that, once it is approved by the Food and Drug Administration, elinzanetant could be a blockbuster drug in the United States and a "game-changer" for women who want or need an alternative to estrogen replacement therapy to combat VMS.
Bayer touts it as the first such drug that targets both the neurokinin-1 and 3 (NK-1 and 3) receptors in the hypothalamus region of the brain. They are estrogen-sensitive neurons that react to a decrease of the hormone, such as during menopause, by becoming enlarged and disrupting the body's heat control mechanisms, thus triggering episodes of VMS.
