18 September 2017 - - Boca Raton, Florida-based women's health care product company TherapeuticsMD, Inc. (NYSE American: TXMD) has submitted additional endometrial safety information that was requested by the Food and Drug Administration in its recent general advice letter to the company regarding the New Drug Application for TX-004HR, the company said.
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 re-submit the NDA for TX-004HR shortly after the meeting.
According to the company, 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.
TherapeuticsMD is focused on developing and commercializing products exclusively for women. With its SYMBODA technology, the company 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 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 due to menopause.