TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company ("TherapeuticsMD" or the "Company"), announced today positive outcomes of a rabbit irritation study for TX 004-HR (formerly referred to as TX 12-004-HR), a rapidly acting estrogen vaginal preparation capsule (VagiCap).
This toxicity study involved vaginal administration of VagiCap in New Zealand white female rabbits. The study demonstrated that TX 004-HR was "non-irritant" following a 28-day repeated application to the vaginal mucosa.
This toxicity study was conducted to meet a specific FDA requirement for any new component of a novel delivery system, such as the VagiCap vaginal softgel capsule for estradiol. Because the components of the VagiCap had not been previously studied in vaginal delivery, the capsule was required to pass this local toxicity assessment at repeated doses.
Sebastian Mirkin, M.D., Chief Medical Officer of TherapeuticsMD, said, "We are pleased that our VVA drug candidate has passed this toxicity hurdle. These results will enable us to move forward to late phase clinical testing.""The VVA market is growing substantially due to increasing demands by maturing women who are remaining sexually active longer and finding dissatisfaction with currently available VVA therapies. We are committed to developing this drug candidate to offer women a significant advancement in treatment options and to fill their unmet needs," concluded Robert Finizio, Chief Executive Officer and Co-Founder of TherapeuticsMD. About TX 004-HR TX 004-HR estradiol VagiCap is an investigational drug enabling the vaginal administration of estradiol that is designed to treat moderate to severe VVA symptoms associated with menopause. TX 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 The North American Menopause Society (NAMS) estimates that up to 50% of postmenopausal women are affected by VVA, which results from the decrease in estrogen that occurs with menopause. The U.S. Census estimates the number of postmenopausal women in the U.S. will exceed 50 million 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 currently projects the global market for postmenopausal VVA will reach $3.1 billion by 2019.