US-owned Sucampo Pharma Europe has filed a Marketing Authorization Application in Switzerland for Amitiza (lubiprostone) for the indication of chronic idiopathic constipation in adults. The MAA was submitted to Swissmedic by the firm's branch office in Basel.
The submission is part of the ongoing development of Amitiza 24mcg, which was first introduced in the USA in April 2006 for the treatment of CIC on in adults. In May 2008, the drug was launched for the treatment of irritable bowel syndrome with constipation in adult women. Earlier this year, MAAs were filed in nine European countries for CIC in adults at 24mcg and these are currently under review.
"Building upon the success of Amitiza in the USA, we are systematically developing additional marketing opportunities outside the USA. This application is a continuation of these efforts as well as an ongoing expansion of our European operations," said Ryuji Ueno, founder and chief executive of Sucampo Pharmaceuticals.
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