TherapeuticsMD Reports Closing of Enrollment in REJOICE Trial for TX-004HR

TherapeuticsMD Inc.

, an innovative women's healthcare company, today announced that the Company has completed patient enrollment in The Rejoice Trial, a phase 3 clinical trial of TX-004HR (estradiol in VagiCap™) to evaluate multiple doses of an investigational, applicator-free vaginal estradiol for the treatment of pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. TX-004HR is an investigational bio-identical estradiol softgel capsule administered vaginally without the need for an applicator. The Rejoice Trial is also collecting efficacy data on vaginal dryness, and vaginal and/or vulvar itching or burning. "Recent studies have shown that current therapies used to treat VVA generate some concerns from women with respect to their efficacy, convenience and safety," stated Sebastian Mirkin, MD., Chief Medical Officer of TherapeuticsMD. "TX-004HR was designed to try to address these unmet needs. Completion of patient recruitment in the Rejoice Trial marks an important milestone in our development efforts and we look forward to disclosing topline results from the Rejoice Trial later this year." Trial Design A pivotal safety and efficacy study, the Rejoice Trial is a randomized, multicenter, double-blind, placebo-controlled study evaluating three strengths of TX-004HR – 4 mcg, 10 mcg and 25 mcg. The 4 mcg strength represents a new low-dose option. The 12-week trial enrolled over 700 participants in approximately 100 sites across the United States and Canada.