TherapeuticsMD reports Phase III Replenish Trial positive top-line data of TX-001HR to treat VMS


US-based healthcare company TherapeuticsMD has reported positive top-line results of its pivotal Phase III Replenish Trial of TX-001HR to treat moderate-to-severe vasomotor symptoms (VMS) due to menopause in post-menopausal women with an intact uterus.

TX-001HR is a combination of 17ß-estradiol and natural progesterone being investigated to treat vasomotor symptoms related to menopause.

It is based on the company's SYMBODA technology, which allows partial and complete solubilisation of estradiol and progesterone into medium-chain fatty acid oils often derived from coconut oil.

The Replenish Trial assessed four doses of TX-001HR and placebo, while examining 1,835 post-menopausal women aged 40 to 65.

The co-primary efficacy endpoint of the study was to determine the baseline change in the incidence and severity of hot flashes at weeks four and 12, compared with patients receiving placebo.

The primary safety endpoint of the study was to track the incidence of endometrial hyperplasia after 12 months of treatment.

The secondary endpoints of the Replenish trial were evaluated using well-validated patient reported outcome tools, including the Menopause-Specific Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder analysis rate.

Results suggested dosages TX-001HR estradiol 1mg/progesterone 100mg and TX-001HR estradiol 0.5mg/progesterone 100mg met all the co-primary efficacy endpoints and the primary safety endpoint.

"The Replenish Trial demonstrated for the first-time safety and robust efficacy for the treatment of hot flashes at multiple doses of TX-001HR."

The trial has also exhibited a dose response favouring the higher doses of estradiol in combination with progesterone, and the availability of multiple TX-001HR doses will enable individualised therapy to cater to a diverse population of women.

TherapeuticsMD chief medical officer Sebastian Mirkin said: “The Replenish Trial demonstrated for the first-time safety and robust efficacy for the treatment of hot flashes at multiple doses of TX-001HR.

 “If approved, TX-001HR estradiol 1mg/progesterone 100mg and TX-001HR estradiol 0.5mg/progesterone 100mg would provide TherapeuticsMD with a complete portfolio to meet the demands of women currently taking unapproved compounded hormones for the treatment of VMS, along with the healthcare providers and pharmacies that prescribe and compound these products.”

TherapeuticsMD is conducting an additional efficacy and safety analysis of the Replenish Trial data.


Image: Graphical illustration of baseline change in weekly frequency of moderate-to-severe hot flashes. Photo: courtesy of Business Wire.