Sucampo Pharmaceuticals, Inc. (SCMP) and Abbott (ABT) announced that Sucampo Pharma, Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, 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.
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 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. The application also included data from previous trials conducted in the United States, Canada and Europe.
"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, Sucampo's Chairman and Chief Executive Officer. "We look forward to working with Abbott to meet the needs of these patients in Japan."
by RTT Staff Writer
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