A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2017

At a glance

  • Drugs Estradiol (Primary)
  • Indications Atrophic vaginitis; Dyspareunia
  • Focus Registrational; Therapeutic Use
  • Acronyms REJOICE
  • Sponsors TherapeuticsMD
  • Most Recent Events

    • 19 Dec 2017 According to a TherapeuticsMD media release, FDA has accepted NDA resubmission for TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia)and, acknowledged that the resubmission is a complete, class 2 response to the CRL received on May 5, 2017 for TX-004HR. The PDUFA target action date for the completion of the FDA's review is May 29, 2018.This NDA resubmission based on the data from this trial.
    • 29 Nov 2017 According to a TherapeuticsMD media release, the company has resubmitted the New Drug Application for TX-004HR, for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, with the U.S. Food and Drug Administration (FDA). The company expects the acceptance of the NDA resubmission within 30 calendar days. The FDA will classify the NDA resubmission as Class 1 or 2 upon acceptance of the resubmission.
    • 06 Nov 2017 According to a TherapeuticsMD media release, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study.
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