TherapeuticsMD reports results of meeting with FDA regarding NDA for 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, a symptom of vulvar and vaginal atrophy due to menopause. On June 14 the Company participated in a Type A Post-Action Meeting with the Division of Bone, Reproductive, and Urologic Products of the FDA to discuss the Complete Response Letter that the Company previously received for the NDA for TX-004HR. The meeting enabled the Company to present new information that the Company believes could address concerns raised by the FDA in the CRL and positively affect the status of the NDA for TX-004HR. The Company has received the minutes of the meeting and, per the FDA's request, has formally submitted the new information for consideration related to the NDA for TX-004HR. The Company expects to have additional clarity on the pathway forward for the NDA for TX-004HR in the coming weeks.