SPI subsidiary Sucampo Pharmaceuticals has received approval from the Ministry of Health, Labor and Welfare in Japan for Amitiza (lubiprostone), a prescription drug for the treatment of chronic constipation, excluding constipation caused by organic diseases.
Amitiza is a prostone, a local activator of type-2 chloride ion channels (ClC-2) in cells lining the small intestine.
In September 2010, a marketing application was submitted to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza.
Data from a Phase 3 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 were included in the application.
It also included data from previous trials conducted in the United States, Canada and Europe.
Sucampo's chairman and chief executive officer Ryuji Ueno said this is Japan's first-ever approval for a prescription drug for chronic constipation as it helps the company achieve its objective of bringing medicines with novel mechanisms of action to patients with unmet medical needs on a global basis.
"We look forward to working with Abbott to meet the needs of these patients in Japan."
Sucampo and Abbott Japan entered into a license, commercialization and supply agreement for AMITIZA in Japan in 2009.
The US approved Amitiza for the treatment of two constipation-related indications and Switzerland for one constipation-related indication.
