FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause
In 3 Phase 3 trials, elinzanetant reduced the frequency and severity of moderate to severe vasomotor symptoms, and improved sleep disturbances.
Bayer has submitted a new drug application (NDA) to the FDA for its investigational compound elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist for the nonhormonal treatment of moderate to severe vasomotor symptoms associated with menopause.1
FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause / loran4a - stock.adobe.com
The therapy, which is in late-stage clinical development, is administered orally once a day and works by modulating estrogen sensitive neurons in the hypothalamus. This leads to a decrease in estrogen and a hyperactivation of the thermoregulatory pathway, which disrupts mechanisms of body heat control. Bayer said elinzanetant could also decrease menopause-associated sleep disturbances.
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“Half of the world’s population will experience menopause, with 27 million women in the US currently experiencing this transition,” Christine Roth, executive vice president of Global Product Strategy and Commercialization at Bayer, said in a release.1 “Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limitations of treatment options available.”
The NDA submission for elinzanetant was supported by data from the phase 3 OASIS clinical development program. The program includes 4 phase 3 studies: OASIS 1, 2, 3, and 4. The NDA was primarily based on data from the OASIS 1, 2, and 3 trials. OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies evaluating the efficacy and safety of elinzanetant in women over 26 weeks. Oasis 3 is investigating the therapy over a 52 week period.
Data from the 3 studies showed that 120 mg of elinzanetant taken once daily reduced both the frequency and severity of moderate to severe vasomotor symptoms, which are also known as hot flashes. In Oasis 1 and 2, the therapy also demonstrated consistent improvements in key secondary endpoints, including a reduction in the frequency of hot flashes at week 1, improvement in sleep disturbances and menopause-related quality of life. The safety profile of elinzanetant was also seen to be favorable, with headache and fatigue being the most commonly reported adverse events.
Oasis 4, which is an expansion of the phase 3 program, is investigating the safety and efficacy of elinzanetant in women with moderate to severe hot flashes as a result of endocrine therapy for the treatment or prevention of breast cancer. Bayer also said that it is conducting an exploratory phase 2 study, called NIRVANA, investigating elinzanetant for the treatment of sleep disturbances associated with menopause.
Bayer said in the release that it intends to submit applications for marketing authorizations of elinzanetant to other global health authorities.
“The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women,” Roth said in the news release.1 “This further underscores our position as leaders in Women's Health and our dedication to addressing the unmet medical needs of women globally.”
READ MORE: Women's Health Resource Center
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