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BETHESDA, Md. — Sucampo Pharmaceuticals Inc. has gained approval from the Food and Drug for expanded use of Amitiza, a medication for constipation.
The company said Tuesday that the FDA approved its 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 adults with chronic, noncancer pain.
Amitiza is sold in the United States through a partnership of Sucampo and Takeda Pharmaceuticals USA Inc.
Sucampo noted that the approval marks the third indication for Amitiza in the United States. The medication also is approved in the U.S. for the treatment of chronic idiopathic constipation in adults (24 mcg twice daily) and irritable bowel syndrome with constipation in adult women (8 mcg twice daily).
Opioid-induced constipation is a common adverse effect of chronic opioid use. According to Sucampo, there are more than 200 million prescriptions for opioid use in the U.S. annually, and many are for noncancer chronic pain.
"This approval from the FDA, which received priority review status, provides the first and only oral treatment option for opioid-induced constipation in adult patients with chronic, noncancer pain. As a locally acting ClC-2 channel activator, Amitiza enhances chloride secretion together with intestinal fluid, which is important in its role in treating OIC," stated Ryuji Ueno, chairman, chief scientific officer and chief executive officer at Sucampo. "With this third indication for Amitiza, we are pleased to be able to provide physicians an important new option to help treat the unmet needs of their patients."
About 40% to 80% of patients taking opioids chronically for noncancer pain report constipation, Sucampo reported, and some patients may discontinue opioid therapy and endure pain rather than suffer from the constipation the opioids cause.
"We are pleased with the FDA approval of this new indication for Amitiza," commented Charlie Baum, vice president of U.S. medical affairs for Takeda. "It is critical that we continue to identify and respond to the needs of physicians and their patients with OIC."
