Bonafide Health has announced the release of Thermella, a novel hormone-free and prescription-free neurokinin 3 receptor (NK3R) antagonist designed to alleviate hot flashes and night sweats experienced during menopause. This botanical supplement aims to rebalance the body’s thermoregulatory center, offering a new option for women seeking relief from vasomotor symptoms (VMS).
Mechanism of Action
Thermella operates by blocking the neurokinin B (NKB) pathway, a mechanism similar to prescription options like VeozahTM. The formulation includes a blend of optimized curcumin extract, decaffeinated green tea extract, and spirulina extract, all known for their NK3R antagonist effects.
Clinical Trial Results
The launch is supported by two research studies presented at The Menopause Society’s annual meeting. The first study, a three-month, double-blind, placebo-controlled trial, involved 74 peri- and postmenopausal women aged 40-65. Participants consumed two capsules daily for 12 weeks. The results indicated:
- 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 observed.
- No serious adverse events were reported, nor were there significant changes in metabolic panel health markers, including liver enzymes.
Safety Profile
The second study presented at the meeting demonstrated that the proprietary blend used in Thermella showed no effect on MCF-7 cells, a common estrogen-sensitive breast cancer cell line, suggesting a favorable safety profile.
Expert Commentary
"These findings are incredibly exciting and welcome news for women suffering with VMS symptoms," said Dr. Alyssa Dweck, MS MD FACOG, Bonafide’s Chief Medical Officer and co-author of one of the studies. Dr. Mary Jane Minkin, MD FACOG, clinical professor at Yale University School of Medicine and co-author of one of the studies, added, "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."
Market and Future Investments
Bonafide plans to invest over $3 million this year in scientific research and development to address the unmet need for hormone-free menopause treatments derived from natural ingredients. Thermella is available for purchase without a prescription on Bonafide’s website, with monthly subscriptions at $45/month and 3-month subscriptions at $40/month ($120 paid quarterly).