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# FDA Reverses More-Data Request on Vaginal Pain Drug
- URL: https://www.fdaweb.com/fda-reverses-more-data-request-on-vaginal-pain-drug/
- Published: 2017-11-06T12:00:00.000Z
- Updated: 2026-09-14T23:00:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140059

In a move that may signal the agency’s increasing reliance on [real world data](https://www.fdaweb.com/fda-has-drug-evidence-flexibility-califf-staff/), FDA has reversed its decision to require TherapeuticsMD to submit additional endometrial safety information to address the only approvability issue raised in a May-issued complete response letter (CRL) on an NDA for TX-004HR, the company’s investigational applicator-free estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause.

TherapeuticsMD says it met in person 11/3 with the staff at CDER’s Division of Bone, Reproductive, and Urologic Products and they agreed to the resubmission of the NDA without the need for an additional pre-approval study. Instead, the company says it will commit to conduct a post-approval observational study. The resubmission will occur within the coming weeks.

The agency’s CRL raised concern about a lack of long-term endometrial safety data beyond the 12 weeks studied in the pivotal phase 3 Rejoice Trial, the company says. “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 NDA,” it says. “The CRL did not identify any issues related to the efficacy of TX-004HR and did not identify any approvability issues related to chemistry, manufacturing, and controls.”