Sucampo Pharma Europe, Ltd, a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc, withdrew its European marketing authorization application (MAA) for lubiprostone, 24 mcg, for the indication of Chronic Idiopathic Constipation (CIC).
Sucampo stated that its decision to withdraw the MAA was strategic based upon lubiprostone's projected commercial position in the global market. Sucampo will evaluate its opportunities to obtain an appropriate label in the European Union based on the fact that lubiprostone is the only product registered for chronic therapy for CIC and Irritable Bowel Syndrome with Constipation (IBS-C).
In connection with the announcement, Sucampo confirmed its confidence in lubiprostone in the United States, where the drug has been approved and prescribed as a treatment for CIC in adults since 2006 and as a treatment for irritable bowel syndrome in adult women since 2008, as well as in Japan, where lubiprostone is in an ongoing phase-3 trial as a potential treatment for CIC.
Amitiza (lubiprostone) is co-marketed in the US by Sucampo Pharma Americas, Inc and Takeda Pharmaceuticals North America, Inc, and is being co-developed in Japan by Sucampo Pharma Ltd and Abbott Japan Co Ltd.
Sucampo Pharma, an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines based on prostones.