TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's healthcare company ("TherapeuticsMD" or the "Company"), announced today that its investigational drug, TX 12-004-HR estradiol VagiCap™, improved objective measures of VVA in a phase 1 clinical study. The study evaluated the efficacy and safety of a 10µg dose of TX 12-004-HR vs. placebo over a two-week period in 48 postmenopausal women with symptoms of VVA. Statistically significant differences were found between the treatment and placebo groups, with the treatment group showing changes in Maturation index (cell composition) and pH more closely resembling that found in premenopausal women with healthy, non-atrophied vaginal tissue.
Up to 50% of postmenopausal women are estimated to be affected by this condition which results from the decrease in estrogen that occurs with menopause. Despite symptoms that can adversely affect quality of life, sexual function, and urogynecologic health and include vaginal and vulvar pain, irritation, itching, burning, discharge, and painful intercourse, approximately 75% of women with symptoms do not seek treatment. The global market for postmenopausal VVA is currently estimated at over $1.6 billion and is projected to reach $3.1 billion by 2019.
TherapeuticsMD is developing TX 12-004-HR, its investigational drug for the treatment of VVA, for review by the U.S. Food and Drug Administration (FDA). TX 12-004-HR leverages the Company’s solubilized estradiol technology in a unique, tear-shaped softgel capsule designed for easy intravaginal insertion.
“VVA has a deleterious effect on a woman’s emotional and physical intimacy. As a company dedicated to meeting women’s health needs at every life stage, we are pleased that this phase 1 study suggests our investigational softgel capsule may offer a benefit. We are encouraged by the statistically significant improvements demonstrated here with our lowest dose and look forward to initiating a 12-week, phase 3 clinical trial to evaluate the efficacy of both 10µg and 25µg doses on the exact same measures evaluated in this trial,” said Julia Amadio, Chief Product Officer of TherapeuticsMD.