TherapeuticsMD updates on regulatory progress of vaginal pain candidate

US women’s healthcare specialist TherapeuticsMD (NYSE: TXMD) saw its shares dip 1.23% to $5.60 in after-hours trading on Thursday after it 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 Food and Drug Administration, as requested by the agency, to address the only approvability issue raised in the Complete Response Letter (CRL) for the New Drug Application for TX-004HR, which was the lack of long-term safety data beyond the 12 weeks studied in the REJOICE Trial.

TherapeuticsMD 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.