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Friday, January 14, 2022 5:15:50 AM
Ebopiprant for Treatment of Preterm Labor: Preparations are ongoing to initiate a Phase 2b clinical study in Q4:21. The Phase 2b dose ranging study will build on the recently announced PROLONG Phase 2a proof-of-concept study, which demonstrated early clinical efficacy and safety in pregnant women with spontaneous preterm labor. Given ebopiprant is currently the only known product in development for this indication and based on its innovative mechanism of action and positive topline data, the Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptive design. In parallel with development of ebopiprant in Europe and Asia, the Company is also actively evaluating the regulatory strategy for ebopiprant development in the United States, where there are currently no FDA-approved tocolytic medications available for treatment of preterm labor.
likely something changed after this:
https://www.organon.com/news/organon-and-obseva-enter-global-license-agreement-to-develop-and-commercialize-ebopiprant-obe022-an-investigational-agent-being-evaluated-as-a-first-in-class-treatment-for-preterm-labor/
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