TherapeuticsMD announced positive data for its investigational hormone therapy, TX-001HR, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Study findings were presented at the annual meeting of the Endocrine Society, ENDO 2017.
The Replenish Trial was a pivotal Phase 3 study evaluating the efficacy and safety of four doses of TX-001HR in menopausal women. The trial met all the co-primary efficacy endpoints, showing that two doses of TX-001HR (estradiol 1mg/progesterone 100mg and estradiol 0.5mg/progesterone 100mg) achieved a statistically significant and clinically meaningful reduction in both the frequency and severity of hot flashes vs. placebo at Weeks 4 and 12. Additionally, both doses also showed statistically significant improvement in the secondary endpoint of both total and vasomotor menopause specific quality-of-life questionnaire (MENQOL) scores at Week 12, and maintained through 6 and 12 months.
Additional data from the Replenish Trial, including the analysis on endometrial safety, were also presented. Findings showed that treatment with TX-001HR resulted in no cases of endometrial hyperplasia or malignancy in all treatment groups, meeting the recommendations established by the Food and Drug Administration’s (FDA) draft guidance. The study also found TX-001HR to be safe and well-tolerated, with headache, nasopharyngitis, breast tenderness, and upper respiratory infection as the most commonly reported adverse events.
TX-001HR is the first bio-identical combination hormone therapy of 17ß-estradiol and progesterone in a single oral softgel.
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