Tesofensine regulatory update

After receiving written feedback from FDA and EMA regarding development of obesity candidate tesofensine, NeuroSearch said it believes a Phase III program for the triple monoamine reuptake inhibitor should include 2 1-year trials evaluating weight loss as the primary endpoint, as well as a cardiovascular outcomes trial of >2 years duration. The CV outcome trial will require 5,000-7,000 patients. NeuroSearch said it will not invest further in tesofensine in-house and is seeking a partner for further development and commercialization. ...