Sucampo Pharmaceuticals, Inc. (SPI) today announced that it has received a $10 million milestone payment from Takeda Pharmaceutical Company Limited (Takeda), pursuant to the existing collaboration and license agreement between SPI and Takeda. The milestone payment was triggered by the commercial launch of AMITIZA ® (lubiprostone) (24 mcg daily) in the United States for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of AMITIZA in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
This is the third indication for AMITIZA, which is also approved in the U.S. for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in adult women (8 mcg twice daily). There are more than 200 million prescriptions for opioid use in the U.S. annually, and a substantial number of these prescriptions are for non-cancer chronic pain. Scientific literature indicates that approximately 40-80% of patients taking opioids chronically for non-cancer pain report constipation. Some patients may discontinue opioid therapy and thereby endure pain, rather than suffer from the constipation the opioids cause.
“Millions of patients in the US have been suffering from OIC, and until the approval of AMITIZA for OIC, which received priority review status from the FDA, there were no oral prescription products available to treat it,” said Sucampo’s Chairman, Chief Executive Officer, and Chief Scientific Officer Ryuji Ueno, M.D., Ph.D., Ph.D. “Opioids decrease secretion of intestinal fluid, one of the key factors in causing OIC. As a locally acting ClC-2 channel activator, AMITIZA restores fluid secretion and can lead to relief for those suffering from OIC. We are pleased that with this third indication for AMITIZA, we can further our mission of meeting the unmet medical needs of patients.”
AMITIZA is a specific activator of ClC-2 chloride channels in the intestinal epithelium, and it bypasses the antisecretory action of opiates. AMITIZA is the world’s first chloride channel activator approved for therapeutic use. With more than seven million prescriptions dispensed worldwide since 2006, it is the first and currently the only oral prescription medicine in the world approved for OIC in adults with chronic, non-cancer pain.
In 2004, SPI and Takeda entered into a collaboration and license agreement for AMITIZA for the United States and Canada.