TherapeuticsMD Announces Submission of Additional Endometrial Safety Information to the New Drug Application for TX-004HR
BOCA RATON, FL, U.S.A. – TherapeuticsMD, Inc. (NYSE American: TXMD), an innovative women’s healthcare company, today announced the submission of the additional endometrial safety information that was requested by the Food and Drug Administration (FDA) in its recent General Advice Letter to the company to the New Drug Application (NDA) for TX-004HR. The company has scheduled a formal meeting with the FDA for November 3, 2017, at which the company expects to learn if this additional endometrial safety data addresses the lack of long-term safety identified in the Complete Response Letter for the NDA for TX-004HR. The company currently plans to resubmit the NDA for TX-004HR shortly after the meeting.
The submission includes a comprehensive, systematic review of the medical literature on the use of vaginal estrogen products and the risk of endometrial hyperplasia or cancer, including the safety data from the recently published Women’s Health Initiative Observational Study of vaginal estrogen use in postmenopausal women and information on the relevance of the first uterine pass effect for low-dose vaginal estrogen products.
“Our comprehensive, systematic review of the medical literature on the use of vaginal estrogen products is compelling, and the totality of the data demonstrates that these products are not associated with increased risks of endometrial hyperplasia or cancer,” said TherapeuticsMD chief clinical officer Brian Bernick. “We believe this is an important step towards the approval of our NDA for TX004HR, and we look forward to meeting with the FDA in November to discuss our path forward.”
TherapeuticsMD, Inc., is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s late-stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.
