Posted by Michael Wonder on 09 May 2017
TherapeuticsMD receives complete response letter from FDA for TX-004HR new drug application
8 May 2017 - No approvability issues identified by FDA related to efficacy or CMC.
TherapeuticsMD today announced that it received a complete response letter from the U.S. FDA regarding the new drug application 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 due to menopause.
In the CRL, the only approvability concern raised by the FDA was the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice trial. No cases of endometrial hyperplasia were observed in the Rejoice trial at the end of week 12 for all the doses studied and included in the application.
