TherapeuticsMD has positive data on Phase 3 menopause med
TherapeuticsMD, Inc. (NYSE: TXMD) today announced that data on TX-001HR, an investigational bio-identical hormone therapy combination of 17ß-estradiol and progesterone in a single, oral softgel, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause, was presented at ENDO 2017, the annual meeting of the Endocrine Society in Orlando, Florida, April 1-4. The positive results of the pivotal phase 3 Replenish Trial data were featured in an oral and a poster presentation.
In the oral presentation today, Rogerio Lobo, M.D., professor of Obstetrics and Gynecology and Director of the Reproductive Endocrinology Program at Columbia University, reviewed the detailed findings from the Replenish Trial, the phase 3 study that evaluated the safety and efficacy of four doses of TX-001HR. The Replenish Trial demonstrated that two doses of TX-001HR (estradiol 1 mg/progesterone 100 mg and estradiol 0.5 mg/progesterone 100 mg) achieved a statistically significant and clinically meaningful reduction in both the frequency and severity of hot flashes compared to placebo at weeks 4 and 12, meeting all the co-primary efficacy endpoints.
Secondary endpoint data presented by Dr. Lobo also showed statistically significant improvement in both total and vasomotor menopause specific quality-of-life questionnaire (MENQOL) scores at week 12 and maintained through six and 12 months for these two doses of TX-001HR, further supporting the primary efficacy data shown in the Replenish Trial. MENQOL is a validated tool used to measure quality-of-life in postmenopausal women.
Dr. Lobo commented, “I am pleased to finally see evidence from a well-controlled trial supporting the use of defined doses of bio-identical estradiol and progesterone in combination to treat VMS. These study data, including both the primary and secondary endpoints, suggest that, if approved, TX-001HR will be a valuable new treatment option for women suffering from symptoms of menopause.”
Additionally, David Archer, M.D., professor of Obstetrics and Gynecology and Director of Clinical Research at the Jones Institute at Eastern Virginia Medical School, presented a poster that analyzed endometrial safety in the Replenish Trial. The data showed that TX-001HR resulted in no cases of endometrial hyperplasia or malignancy (0 percent) in all treatment groups, meeting the recommendations established by the U.S. Food and Drug Agency’s (FDA) draft guidance.
The most common adverse events in the Replenish Trial (>5 percent) reported on average in all the active treatment groups were headache, nasopharyngitis, breast tenderness, and upper respiratory infection. There were no unexpected safety signals.
“TX-001HR is the first bio-identical combination hormone therapy of estradiol and progesterone to demonstrate safety and efficacy data in a large, well-controlled, randomized clinical trial,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “If approved, TX-001HR would provide a validated new treatment option for the millions of postmenopausal women who are currently taking unapproved compounded hormones for the treatment of moderate to severe vasomotor symptoms.”
Both the oral and poster presentations from ENDO 2017 are available in the “Investors & Media” section of the company’s website at http://www.therapeuticsmd.com.