Amitiza (Sucampo/Takeda) success in Phase III safety trial for OBD

Top line results are reported by Sucampo Pharma from an open-label 439 patient, 36 week, Phase III clinical trial designed to evaluate the long-term safety and efficacy of Amitiza (lubiprostone) for patients with Opioid-Induced Bowel Dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone.Lubiprostone met the primary endpoint of demonstrating overall safety and secondary endpoints, including changes from baseline in frequency of spontaneous bowel movements. There were no serious drug-related adverse events in the study. Additionally, treatment with lubiprostone demonstrated consistent improvements over baseline with respect to bowel frequency rates and other OBD-related symptoms at each timepoint measured throughout the study. Sucampo aree preparing to file the supplemental NDA in mid-2012 with a request for priority review. The FDA approved Amitiza for idiopapathic constipation 20 July 2006 and IBS constipation in 29 April 2008.The drug is filed for EU approval. Takeda have marketing rights for the USA and Canada.