BETHESDA, Md. & DEERFIELD, Ill.–(BUSINESS WIRE)–Apr. 23, 2013– Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Sucampo’s supplemental new drug application (sNDA) for Amitiza (lubiprostone) (24 mcg twice daily) as the first and only oral medication 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.
Opioid-based medicines are widely used in the management of chronic pain, with OIC being a common adverse effect of chronic opioid use. Some patients may discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.
Amitiza is a specific activator of ClC-2 chloride channels in the intestinal epithelium. Amitiza, via activation of apical ClC-2 channels in the intestinal epithelium, bypasses the antisecretory action of opiates.
This approval is based on results from Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids (among them morphine, oxycodone, and fentanyl) chronically for non-cancer pain, as well as a long-term, open-label safety study, which provides additional support for use in this population. Two of the Phase 3 studies met their overall efficacy endpoint, while a third Phase 3 study did not.
About Opioid Induced Constipation (OIC)
OIC is a common adverse effect of chronic opioid use. Binding of opioids to peripheral opioid receptors in the gastrointestinal tract results in absorption of electrolytes, such as chloride, and subsequent reduction in small intestinal fluid. In addition, activation of enteric opioid receptors results in abnormal GI motility. Together, these processes result in OIC, which is characterized by infrequent and incomplete evacuation of stool, hard stool consistency, and straining associated with bowel movements.
Amitiza (lubiprostone) capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. Amitiza is also indicated for irritable bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice daily).