New York, NY, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Bonafide Health, LLC, a women’s healthcare company committed to providing effective and clinically studied solutions for common perimenopause and menopause symptoms, announces the launch of Thermella, a hormone-free, prescription-free option that relieves hot flashes and night sweats. Thermella, a neurokinin 3 receptor (NK3R) antagonist, relieves symptoms at the source in as early as two weeks by rebalancing the body’s thermoregulatory center through blocking the neurokinin B (NKB) pathway, the same mechanism of action as current prescription options, such as VeozahTM.
Supporting the launch of this innovative product, Bonafide shared the results of two research studies at The Menopause Society’s annual meeting earlier this month. The first was a three-month, double-blind, placebo-controlled study involving 74 (with 68 completing the trial and 65 used in analysis) peri- and postmenopausal women aged 40-65, who consumed 2 capsules daily of the blend, for 12 weeks.1 This study demonstrated that the supplement significantly reduced the frequency of hot flashes and night sweats in peri- and postmenopausal women, confirming the efficacy of the first hormone-free NK3R antagonist botanical blend in reducing vasomotor symptoms (VMS).
The initial results for Thermella are highly encouraging:1,2
- Over 90% of participants experienced improvement in moderate to severe hot flashes by 12 weeks, with significant improvement noted as early as 2 weeks
- Women reported average reductions of 60% for total VMS and 71% for moderate to severe hot flashes, by 12 weeks
- Significant improvements in quality of life and sleep were indicated alongside use, as measured by daily interferences of hot flashes
- No serious adverse events (AEs) were experienced during the study as well as no significant changes in full metabolic panel health markers, including liver enzymes
- In the second study presented during the annual meeting, the proprietary blend used in Thermella showed no effect on MCF-7 cells, a common estrogen-sensitive breast cancer cell line. This suggests a favorable safety profile for use in women looking for a hormone-free option for the treatment of VMS3
"These findings are incredibly exciting and welcome news for women suffering with VMS symptoms,” says Dr. Alyssa Dweck, MS MD FACOG, Bonafide’s Chief Medical Officer and co-author of one of the studies. "The hormone-free nature of this botanical blend offers a novel option, made with naturally derived ingredients, for women who are interested in a non-hormonal and non-drug solution.”
Thermella is made from a concentrated blend of optimized curcumin extract, decaffeinated, purified green tea extract, and spirulina extract. These components are known for their NK3R antagonist effects and reduction of NKB levels.
“Many women prefer a non-medication approach to their menopausal symptoms, particularly hot flashes. Thermella now offers them this option, with demonstrated effectiveness and safety," adds Dr. Mary Jane Minkin, MD FACOG, clinical professor at Yale University School of Medicine and co-author of one of the studies.
This year, Bonafide will spend over $3MM on scientific research and development to address the lack of innovation in menopause treatments derived from natural ingredients. Menopause is an often-overlooked segment of the healthcare industry, leaving a massive unmet need for hormone-free, drug-free products that are clinically tested and both safe and effective. Since its inception, the company has conducted or sponsored 35+ clinical trials of both products and specific ingredients. Today in the U.S., over 17,350 healthcare providers currently recommend Bonafide products to their patients. Bonafide partners with FDA-registered, GMP (good manufacturing practice certified) manufacturing facilities and rigorously tests each of their products for consistency, quality, purity, and potency.
Thermella is available for purchase without a prescription on Bonafide’s website www.hellobonafide.com – where monthly subscriptions are $45/m, and 3-month subscriptions are $40/m ($120 paid quarterly).
ABOUT BONAFIDE HEALTH, LLC
Bonafide Health was launched with a simple mission: to provide women with safe and highly effective symptom relief throughout their menopause journey. As part of Bonafide's scientific research and product development process, the brand prides itself on their deep understanding of the biological and physiological changes that affect women due to hormonal fluctuations experienced with age. Trusted by more than 17K healthcare professionals, Bonafide provides first-of-its-kind, evidence-based solutions developed from naturally derived ingredients that are hormone-free and drug-free. To learn more visit www.hellobonafide.com
Resources
- Lederman, S., Minkin, M. J., Nachtigall, L., Sritharan, S., Rubio, J., Recker, S., & Lin, L. (2024, September). A randomized, double-blind, placebo-controlled study to evaluate the effects of a nonhormonal neurokinin B inhibiting supplement on vasomotor symptoms in menopausal women. Presentation at The Menopause Society, Chicago, IL, USA.
- Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women. Clinical Trial Registration: NCT05813067. Data on File.
- Bernsley, D., Dweck, A., Komorowski, J. (2024, September). The lack of estrogenic effects of a novel botanical blend on MCF-7 breast cancer cell proliferation. Presentation at The Menopause Society, Chicago, IL, USA.
Attachments
Ann Pechaver Bonafide® Health, LLC 802-578-7512 apechaver@Bonafidehealth.com
