Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).
“Opioid-induced bowel dysfunction is a common, painful and debilitating side effect of opioid-based pain therapy. There is a significant need among patients for another therapeutic option to manage OBD.”
M. Mazen Jamal, M.D., M.P.H., Chief of Endoscopy, Long Beach Veterans Affairs' Medical Center, Long Beach, California, and Professor, Department of Medicine, University of California College of Medicine at Irvine, and an investigator in the trial, said, "Opioid-induced bowel dysfunction is a common, painful and debilitating side effect of opioid-based pain therapy. There is a significant need among patients for another therapeutic option to manage OBD."
Gayle Dolecek, Senior Vice President, Research & Development at Sucampo, said, "Based on previous data, we believe that lubiprostone has the potential to be U.S. Food and Drug Administration (FDA) approved as an important new treatment option for patients suffering from OBD. We look forward to completing this study and to announcing its results."
Sucampo plans to enroll a total of 420 patients at up to 140 sites in the U.S. and Europe. Patients will be randomized to receive either placebo or lubiprostone 24 mcg gel capsule twice daily throughout the 12- week treatment period. Patients must have been treated for chronic, non-cancer related pain with any opioid other than methadone for at least 30 days prior to screening, and will continue opioid therapy throughout the study. Patients must have OBD, which is defined as having an average of fewer than three SBMs per week during the three-week screening period with hard or very hard stools, sensation of incomplete evacuation, or moderate to very severe straining with at least 25% of their SBMs while on opioid-based therapy.
Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.