Sucampo Pharma, Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (SPI) has received approval from the Ministry of Health, Labor and Welfare in Japan for Amitiza (lubiprostone), a prescription medicine for the treatment of chronic constipation (excluding constipation caused by organic diseases).
“We are very pleased to receive Japan's first-ever approval for a prescription medicine for chronic constipation as it helps us achieve our objective of bringing medicines with novel mechanisms of action to patients with unmet medical needs on a global basis,” said Ryuji Ueno, MD, Ph.D., Sucampo's chairman and chief executive officer. “We look forward to working with Abbott to meet the needs of these patients in Japan.”
In 2009, Sucampo and Abbott Japan Co. Ltd. entered into a license, commercialization and supply agreement for Amitiza in Japan.
Sucampo submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza in September 2010. The application included data from a phase III efficacy trial in 124 Japanese patients as well as from a long-term open-label safety trial in 209 Japanese patients who received lubiprostone for up to 48 weeks. The application also included data from previous trials conducted in the United States, Canada and Europe.
Thousands of people in Japan live daily with the pain and discomfort of chronic constipation, yet many do not seek physician care. Medical attention could mean early diagnosis and effective, long-term treatment.
Amitiza (lubiprostone) is a prostone, a local activator of type-2 chloride ion channels (ClC-2) in cells lining the small intestine. By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic constipation. Additionally, activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function via the restoration of tight junction protein complexes in ex vivo studies of ischemic porcine intestine.
Amitiza is approved in the United States for the treatment of two constipation-related indications and in Switzerland for one constipation-related indication.
Sucampo Pharmaceuticals, Inc., an international pharmaceutical company, is focused on the discovery, development and commercialization of proprietary drugs based on prostones.