TherapeuticsMD Announces Oral Presentation of Positive Phase 2 and Bioavailability Data on TX-004HR (VagiCapTM)

TherapeuticsMD Inc. (NYSE MKT:TXMD), an innovative women’s healthcare company, announced today that positive results from phase 2 and pharmacokinetic studies of TX-004HR will be presented at the 25th Annual Meeting of The North American Menopause Society, October 15-18, 2014, at the Gaylord National Resort & Convention Center in Washington, D.C.

James H. Pickar, M.D., FACOG, adjunct associate professor of obstetrics and gynecology at Columbia University College of Physicians & Surgeons in New York City, will make the first scientific presentation of a phase 2 pilot safety and efficacy study and pharmacokinetic studies on investigational compound TX-004HR. His oral presentation, “Pilot and Pharmacokinetic Studies of Solubilized Estradiol Administered Vaginally in a Softgel Capsule,” is scheduled for Thursday, October 16 from 4:30-4:45 p.m.

These results “…provide promising news for women who may potentially benefit from a low-dose, locally administered hormone treatment option for relief from the pain and discomfort of menopause-associated vulvar and vaginal symptoms,” Pickar said.

Vulvar and vaginal atrophy (VVA) is a condition resulting from the decrease in naturally occurring estrogen during menopause, resulting in thinning of the vaginal lining and an increase in vaginal pH levels. Although an estimated 32 million women in the United States are currently suffering from symptoms of VVA, only 2.3 million (7 percent) are currently being treated with prescription therapy.†

TherapeuticsMD’s phase 3 Rejoice Trial for this drug candidate began in September 2014 and is investigating 4 mcg, 10 mcg and 25 mcg estradiol doses. The investigational compound TX-004HR 4 mcg dose represents a potentially new low dose local estrogen treatment.

About TherapeuticsMD Inc.

TherapeuticsMD Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its patented SYMBODATM technology platform, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products that enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes three phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under the 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.

Reference

† Kingsberg, Sheryl A., et. al. "Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) Survey." Journal of Sexual Medicine 2013, no. 10, 1790-1799.