The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for TX-004HR (TherapeuticsMD, Inc.), an 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 trial at the end of week 12 for all of the doses studied and included in the NDA.
The CRL did not identify any issues related to the efficacy of TX-004HR and did not point out any approvability issues related to chemistry, manufacturing, and controls.
TherapeuticsMD believes that the NDA was approvable as filed and intends to meet with the FDA as soon as possible to address the agency’s concerns.
Source: TherapeuticsMD; May 8, 2017.