TherapeuticsMD receives letter from FDA regarding TX-004HR
TherapeuticsMD announced a regulatory update regarding the New Drug Application, or 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, or dyspareunia, a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. 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 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 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.