Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

Nov 30 2010

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Abbott (NYSE:ABT) today announced positive top-line data from a 48-week phase 3 long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). The trial demonstrated that lubiprostone was safe and well-tolerated.

“These data demonstrate the lubiprostone is a safe and effective treatment option for Japanese patients with CIC with or without IBS-C, and are consistent with previously reported pivotal phase 3 data for lubiprostone.”

This long-term phase 3 safety trial was an open-label, multi-center study in which Japanese CIC patients received one 24-mcg lubiprostone capsule twice a day for up to 48 weeks. A total of 209 patients were enrolled, 173 patients completed 24 weeks of treatment and 163 patients completed 48 weeks of treatment. The number of patients completing the full 48 week treatment period exceeded the target of 35 patients. Each enrolled patient had a history of fewer than three SBMs per week for at least six months, as confirmed during a 14-day screening period.

The safety results of the trial demonstrated that the most common adverse drug reactions (ADR) in this long-term safety trial were diarrhea (37.3%), nausea (27.3%), chest discomfort (7.2%) and abdominal pain (5.3%) which were transient in duration. The majority of first incidences of ADRs took place during the first two weeks of treatment. The most common mild ADRs were: diarrhea, nausea, chest discomfort, vomiting, abdominal pain, abdominal discomfort and abdominal distension. The most common moderate ADRs were diarrhea, nausea, vomiting and vertigo. There were no severe ADRs.

In February 2009, Sucampo entered into a license, commercialization, and supply agreement for lubiprostone with Abbott Japan Co. Ltd. under which Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC and the right of first refusal to any additional indications for which lubiprostone is developed in Japan. Sucampo continues to lead the development of and regulatory activity for lubiprostone in Japan.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, "We are very pleased that these data are totally consistent with safety and efficacy data from previous phase 3 clinical trials of lubiprostone in the U.S. and Japan. We look forward to updating our recently submitted marketing application in early 2011 with Japan's Pharmaceuticals and Medical Devices Agency with a full analysis of these data."

Gary Winer, Vice President, Pharmaceuticals, Abbott Japan, said, "The long-term safety data for lubiprostone are encouraging and give us hope that Japanese patients suffering from CIC may soon have reason to expect relief from this difficult condition."

Shin Fukudo, M.D. Ph.D., Professor of Behavioral Medicine at Tokohu University Graduate School of Medicine, in Sendai, Japan, said, "These results demonstrate that lubiprostone would be a useful drug for Japanese patients suffering from the life-altering effects of chronic idiopathic constipation."

William D. Chey, Professor, Department of Internal Medicine, Director, Gastrointestinal Physiology Laboratory, and Director, Michigan Bowel Control Program, at the University of Michigan, said, "These data demonstrate the lubiprostone is a safe and effective treatment option for Japanese patients with CIC with or without IBS-C, and are consistent with previously reported pivotal phase 3 data for lubiprostone."

Key efficacy highlights of the long-term safety trial results achieved by lubiprostone include:

The data from this trial are undergoing further analysis and will be submitted to an appropriate medical conference for presentation.

Sucampo is developing lubiprostone in Japan as a potential treatment for patients with CIC. In September 2010, Sucampo submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market lubiprostone 24 mcg for the treatment of CIC. An update to that application, containing a full analysis of the data announced today, will be submitted in early 2011.

SOURCE Sucampo Pharmaceuticals, Inc. and Abbott