Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. announced today that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

Patients received lubiprostone 24-mcg capsule or placebo capsule twice daily for 12 weeks. The primary endpoint was the overall spontaneous bowel movement (SBM) response rate. The response rate for lubiprostone-treated patients was 26.9%.

M. Mazen Jamal, M.D., M.P.H., Chief of Endoscopy, Long Beach Veterans Affairs' Medical Center, Long Beach, California, Professor, Department of Medicine, University of California College of Medicine at Irvine, an investigator in the trial, said, "The results from this Phase 3 trial demonstrate that lubiprostone has the potential to be the first FDA-approved orally administered medicine with the indication to treat OBD in non-cancer, non-methadone patients. OBD can be a painful and debilitating side effect affecting many non-cancer pain patients taking opioids chronically. There are more than 200 million prescriptions for opioid use in the U.S. annually and a substantial portion of these prescriptions are for non-cancer chronic pain. Many patients are not getting the desired relief and there is a significant need for a new medicine to treat this condition."

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and CEO of SPI, commented, "These data confirm the results from a previous phase 3 trial of lubiprostone in OBD patients and together with data from the associated long-term safety trial, complete what we believe are the data requirements to support the submission of a supplemental New Drug Application (sNDA). We expect to submit the sNDA to the U.S. Food and Drug Administration (FDA) in the first half of 2012. In addition, we will discuss the potential for priority review, as we believe that physicians and their patients are actively seeking new therapies to address this condition. If approved, lubiprostone could be the first orally-administered medicine with the indication for OBD, providing another option for patients who need it and further differentiating lubiprostone from the competition."