BOCA RATON, FL, USA I January 28, 2014 I TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company (“TherapeuticsMD” or the “Company”), announced today the final PK results from two studies of TX 12-004-HR, a rapidly acting vaginal preparation capsule versus Novo Nordisk’s Vagifem® (estradiol vaginal tablet). ESTR-1K-499 was an open label, single dose crossover, relative bioavailability study comparing 10µg of TX 12-004-HR to 10µg of Vagifem. ESTR-1K-500 was the study with the same design, but compared 25µg of TX 12-004-HR to 25µg of Vagifem. Study results showed substantially lower systemic estradiol exposure of TX 12-004-HR when compared to Vagifem. In conjunction with the previously reported efficacy of TX 12-004-HR, this PK data suggests that TX 12-004-HR may provide therapeutic advantages over Vagifem.
Side effects associated with vaginal hormone therapy may be related to peak concentrations or overall exposure to the hormones. The maximal concentration of TX 12-004-HR estradiol was about half that observed with Vagifem and the overall exposure to estradiol was approximately one-third that observed with Vagifem. The 24-hour exposure to estradiol in the case of 25µg dose of TX 12-004-HR was 3.3 fold lower than the same dose of Vagifem, and in the case of 10µg dose of TX 12-004-HR was 2.6 fold lower than the same dose of Vagifem. These results would indicate substantially less overall estradiol exposure with TX 12-004-HR, yet the biological effects shown in the pilot phase 1 study reported in October 2013 showed statistically significant results of quantitative endpoints, namely reduction of vaginal pH (p=0.0002) and reduction of vaginal parabasal cells (p
Robert G. Finizio, Chief Executive Officer and Co-founder of TherapeuticsMD, said, “We are pleased that our drug candidate appears to have a lower systemic estradiol exposure while achieving statistically significant clinical efficacy. Our goal is to create a faster-acting, rapidly dissolving VagiCap with less systemic estradiol exposure in a more elegant form. These results will be used to design a development plan and a clinical program to be submitted to Food and Drug Administration (“FDA”) for treatment of VVA in postmenopausal women. The VVA market is growing substantially due to increasing demands by maturing women who are remaining sexually active longer and finding dissatisfaction with current treatment options. We are committed to developing this drug candidate to offer women a significant advancement in treatment options and to meet their unmet needs,” concluded Finizio.
About TX 12-004-HR
TX 12-004-HR estradiol VagiCap is an investigational drug matching the molecular structure of estradiol that is designed to treat moderate to severe VVA symptoms associated with menopause. TX 12-004-HR leverages the solubilized estradiol technology developed by TherapeuticsMD in a unique, tear-shaped softgel capsule designed for easy intravaginal insertion. It is the first softgel capsule for the treatment of VVA being developed for review by the FDA.
About VVA and Market Size
According to the North American Menopause Society (NAMS), up to 50% of postmenopausal women are estimated to be affected by this condition resulting from the decrease in estrogen that occurs with menopause. The U.S. Census estimates this number will exceed 50 million women in 2015. Despite symptoms that can adversely affect quality of life, sexual function, and urogynecologic health and that include vaginal and vulvar pain, irritation, itching, burning, discharge, and painful intercourse, approximately 75% of women with symptoms do not seek treatment. Source Healthcare Analytics estimated the U.S. market for postmenopausal VVA was over $1 billion in 2013, increasing more than 20% over the prior year. GlobalData estimated the global market for postmenopausal VVA is currently projected to reach $3.1 billion by 2019.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We are developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
SOURCE: TherapeuticsMD
Post Views: 132
BOCA RATON, FL, USA I January 28, 2014 I TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company (“TherapeuticsMD” or the “Company”), announced today the final PK results from two studies of TX 12-004-HR, a rapidly acting vaginal preparation capsule versus Novo Nordisk’s Vagifem® (estradiol vaginal tablet). ESTR-1K-499 was an open label, single dose crossover, relative bioavailability study comparing 10µg of TX 12-004-HR to 10µg of Vagifem. ESTR-1K-500 was the study with the same design, but compared 25µg of TX 12-004-HR to 25µg of Vagifem. Study results showed substantially lower systemic estradiol exposure of TX 12-004-HR when compared to Vagifem. In conjunction with the previously reported efficacy of TX 12-004-HR, this PK data suggests that TX 12-004-HR may provide therapeutic advantages over Vagifem.
Side effects associated with vaginal hormone therapy may be related to peak concentrations or overall exposure to the hormones. The maximal concentration of TX 12-004-HR estradiol was about half that observed with Vagifem and the overall exposure to estradiol was approximately one-third that observed with Vagifem. The 24-hour exposure to estradiol in the case of 25µg dose of TX 12-004-HR was 3.3 fold lower than the same dose of Vagifem, and in the case of 10µg dose of TX 12-004-HR was 2.6 fold lower than the same dose of Vagifem. These results would indicate substantially less overall estradiol exposure with TX 12-004-HR, yet the biological effects shown in the pilot phase 1 study reported in October 2013 showed statistically significant results of quantitative endpoints, namely reduction of vaginal pH (p=0.0002) and reduction of vaginal parabasal cells (p
Robert G. Finizio, Chief Executive Officer and Co-founder of TherapeuticsMD, said, “We are pleased that our drug candidate appears to have a lower systemic estradiol exposure while achieving statistically significant clinical efficacy. Our goal is to create a faster-acting, rapidly dissolving VagiCap with less systemic estradiol exposure in a more elegant form. These results will be used to design a development plan and a clinical program to be submitted to Food and Drug Administration (“FDA”) for treatment of VVA in postmenopausal women. The VVA market is growing substantially due to increasing demands by maturing women who are remaining sexually active longer and finding dissatisfaction with current treatment options. We are committed to developing this drug candidate to offer women a significant advancement in treatment options and to meet their unmet needs,” concluded Finizio.
About TX 12-004-HR
TX 12-004-HR estradiol VagiCap is an investigational drug matching the molecular structure of estradiol that is designed to treat moderate to severe VVA symptoms associated with menopause. TX 12-004-HR leverages the solubilized estradiol technology developed by TherapeuticsMD in a unique, tear-shaped softgel capsule designed for easy intravaginal insertion. It is the first softgel capsule for the treatment of VVA being developed for review by the FDA.
About VVA and Market Size
According to the North American Menopause Society (NAMS), up to 50% of postmenopausal women are estimated to be affected by this condition resulting from the decrease in estrogen that occurs with menopause. The U.S. Census estimates this number will exceed 50 million women in 2015. Despite symptoms that can adversely affect quality of life, sexual function, and urogynecologic health and that include vaginal and vulvar pain, irritation, itching, burning, discharge, and painful intercourse, approximately 75% of women with symptoms do not seek treatment. Source Healthcare Analytics estimated the U.S. market for postmenopausal VVA was over $1 billion in 2013, increasing more than 20% over the prior year. GlobalData estimated the global market for postmenopausal VVA is currently projected to reach $3.1 billion by 2019.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. We are developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.
SOURCE: TherapeuticsMD
Post Views: 132
