Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Jun 9 2010

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Abbott (NYSE:ABT) today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

“The results of the lubiprostone trial are very encouraging for Japanese patients suffering from this condition, and the product will be a major breakthrough in improving the quality of life for CIC patients”

The primary endpoint of this trial was a change in the number of spontaneous bowel movements (SBMs) at the end of the first week of treatment. This pivotal, double-blinded, placebo-controlled trial evaluated 124 Japanese CIC patients each of whom received one lubiprostone 24-mcg, or placebo, capsule twice daily for 28 days.

As previously reported, Sucampo continues to conduct a long-term, open-label, multi-center, confirmatory, safety trial in 209 Japanese CIC patients. Top-line results from the safety trial are expected during the fourth quarter of 2010.

"While lubiprostone has been demonstrated to be effective in other ethnic populations, this is the first phase 3 study demonstrating that lubiprostone is effective in improving the signs and symptoms of chronic idiopathic constipation specifically in Japanese patients. As such, it is a milestone in Sucampo's long-term growth strategy to secure international approvals," said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo's Chairman and Chief Executive Officer.

"The results of the lubiprostone trial are very encouraging for Japanese patients suffering from this condition, and the product will be a major breakthrough in improving the quality of life for CIC patients," said Gary M. Winer, President, Abbott Japan, which holds commercialization rights to lubiprostone in Japan.

Sucampo is developing lubiprostone in Japan as a potential treatment for patients with chronic idiopathic constipation (CIC). 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.