TherapeuticsMD, Inc. announced the publication of two manuscripts detailing results of the company’s phase 3 Rejoice Trial in Menopause: The Journal of The North American Menopause Society, a widely-regarded forum for scholarly articles on the leading research related to menopause. The Rejoice Trial is the pivotal phase 3 study of TX-004HR, an investigational bio-identical 17ß-estradiol vaginal softgel capsule, for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women. The manuscripts review the positive results of TX-004HR across all pre-specified primary and secondary endpoints in the Rejoice Trial, as well as data from a pharmacokinetic (PK) substudy demonstrating the low systemic absorption of TX-004HR. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017 to complete its review of the company’s 505(b)(2) NDA submission for TX-004HR. The NDA is supported by the complete TX-004HR clinical program, including positive results of the phase 3 Rejoice Trial, which evaluated the effect of three doses of TX-004HR (4 mcg, 10 mcg and 25 mcg) compared to placebo from baseline to week 12.