Therapeuticsmd, Inc. · NASDAQ:TXMD
Therapeuticsmd — Technical Presentation (December 2016)
9 slides from Therapeuticsmd's technical presentation, Dec 8, 2016
Slide 1: TX-001HR Supplemental Replenish Trial Design And Topline Phase 3 Results
1 TX - 001HR Supplemental Replenish Trial Design And Topline Phase 3 Results December 2016
Slide 2: Forward-Looking Statements
2 Forward - Looking Statements This presentation by TherapeuticsMD, Inc . (referred to as “we” and “our”) may contain forward - looking statements . Forward - looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, o
Slide 3: Replenish Trial Overview
3 Replenish Trial Overview A Phase 3, Double - Blind, Placebo - Controlled, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Estradiol in Combination with Progesterone in Postmenopausal Women with an Intact Uterus
Slide 4: Replenish Trial Study Design - Flow Chart
4 Replenish Trial Study Design - Flow Chart 1. Healthy postmenopausal women aged 40 to 65 years with an intact uterus who were seeking relief from vasomotor symptoms (VMS) and who met all inclusion/exclusion criteria were eligible for 12 months of study treatment. Initial Subject Screening Randomize
Slide 5: Replenish Trial Study Design - Populations
5 Replenish Trial Study Design - Populations • Safety Population (n = all dosed study subjects) • 52 - Week Endometrial Safety Population • A subset of the total safety population group who had a biopsy at week 52 • VMS Efficacy Population (n = ~150 per active arm & placebo) • 12 - Week VMS Efficacy
Slide 6: Current FDA Guidance for VMS Drug Products
6 Current FDA Guidance for VMS Drug Products * Primary Endpoints • Co - primary efficacy endpoints (12 week VMS Efficacy Population) o Mean Change from Baseline to Weeks 4 and 12 in the frequency and severity of moderate and severe vasomotor symptoms versus placebo • Primary safety endpoint (12 mont
Slide 7: Replenish Trial Co-Primary Efficacy Endpoints and Primary Safety Endpoint
7 Replenish Trial Co - Primary Efficacy Endpoints: Mean Change in Frequency and Severity of Hot Flashes Per Week Versus Placebo at Weeks 4 and 12, VMS - mITT Population Estradiol/Progesterone 1 mg/100 mg 0.5 mg/100 mg 0.5 mg/50 mg 0.25 mg/50 mg Placebo (n = 141) (n = 149) (n = 147) (n = 154) (n = 13
Slide 8: Replenish Trial Topline Data: Weekly Frequency of Hot Flashes
8 Replenish Trial Topline Data Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for Weeks 1 to 12 -60 -50 -40 -30 -20 -10 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Mean Weekly Frequency Reduction from Baseline Study Week 1 mg E/100 mg P 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg
Slide 9: Replenish Trial Topline Data: Weekly Severity of Hot Flashes
9 Replenish Trial Topline Data -2 -1.8 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Mean Weekly Reduction in Severity from Baseline Study Week 1 mg E/100 mg P 0.5 mg E/100 mg P 0.5 mg E/50 mg P 0.25 mg E/50 mg P Placebo Mean Change from Baseline in Weekly Severity of Moderate
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