BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
On July 5, 2017, the Company submitted additional endometrial safety information to the FDA, as requested by the Agency, to address the only approvability issue raised in the Complete Response Letter (CRL) for the NDA for TX-004HR, which was the lack of long-term safety data beyond the 12 weeks studied in the REJOICE Trial.
The Company has received a formal General Advice Letter from the FDA stating that an initial review of this information has been completed and requesting that the Company submit the additional endometrial safety information to the NDA for TX-004HR on or before September 18, 2017, including the safety data from a very large, observational study of long-term, real-world users of vaginal estrogens that is pending publication.
The FDA requested approximately six weeks to perform a comprehensive review of these data and has requested a meeting with the Company to discuss the outcome of this review. A tentative meeting date of November 3, 2017 has been set by the Agency. At this meeting, the Company expects to learn if this additional endometrial safety data addresses the lack of long-term safety identified in the CRL. The Company currently plans to re-submit the NDA for TX-004HR shortly thereafter.
“We are very pleased with the FDA’s decision to conduct this comprehensive review and believe that the short timeline and the resources that the FDA has committed demonstrate the significance of the long-term observational study and other information that we provided the Agency,” said TherapeuticsMD CEO Robert G. Finizio. “We believe this is an important step towards the approval of our NDA for TX-004HR and we look forward to working collaboratively with the FDA.”
About TherapeuticsMD, Inc.
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.