Sucampo Pharmaceuticals, Inc. (“Sucampo”) (NASDAQ: SCMP) today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency for AMITIZA® (lubiprostone) 24 mcg twice daily for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate.
“The approval of AMITIZA in the U.K. is an important step in Sucampo’s comprehensive initiative to increase the global reach of AMITIZA. This regulatory milestone follows closely on the approval of AMITIZA in Japan, making AMITIZA the only drug approved for chronic constipation-related indications internationally, inclusive of the United States, Japan, Switzerland and the United Kingdom. We look forward to expanding the AMITIZA franchise into additional indications, such as opioid induced constipation, and geographic locations so that more patients can access this breakthrough medication,” commented Ryuji Ueno, M.D., Ph.D., Ph.D., Chair and Chief Executive Officer of Sucampo.
About Chronic Idiopathic Constipation (CIC)
Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a person suffers specified symptoms for over 12 non-consecutive weeks within a 12 month period. Chronic constipation is idiopathic if it is not caused by other diseases or by the use of medications. Symptoms of CIC include straining, hard stools, bloating and abdominal pain or discomfort.
The following information in the “About Lubiprostone” and “Important Safety Information” sections is based on the United Kingdom-approved Summary of Product Characteristics:
About lubiprostone (AMITIZA)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older in the United States. In Japan, lubiprostone (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In Switzerland, lubiprostone 24 mcg twice daily is indicated for the treatment of chronic idiopathic constipation.