Latest Regulatory Developments
FDA formally withdrew their prior requirement for cardiovascular safety studies in September 2016. The pathway to approval in CIC, the largest market, is now clear. By agreement with FDA, only 2000 further exposures are required in two 12-week RCT pivotal studies in CIC, followed by long-term safety exposures of these 2000 patients for 1 year. This path to approval is consistent with some of the other drugs recently approved for constipation, and is familiar to large pharmaceutical companies.