Sucampo's CIC drug Amitiza gets UK approval

US drugmaker Sucampo Pharmaceuticals (Nasdaq: SCMP) says that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Amitiza (lubiprostone) 24mcg twice daily for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults, when response to diet and other non-pharmacological measures (eg, educational measures, physical activity) are inappropriate.

“The approval of Amitiza in the UK 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, chairman and chief executive of Sucampo.

The current global market for treating IBS is estimated at $689 million and expected to increase to over $1.4 billion by 2018, according to estimates by GlobalData. Net sales of Amitiza as reported to Sucampo by its partner, increased 6.0% to $65.0 million for the second quarter of 2012, compared to $61.4 million in the same period of 2011.