Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A. Inc. (TPUSA) today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA® (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
The filing is based on results from three Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids chronically for non-cancer pain, as well as a long-term, open-label safety study, which provide additional support for use in this population.
“We believe that the data provided in the sNDA application demonstrate that lubiprostone could provide a potential oral treatment option for patients with OIC,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and CEO of SPI. “We are seeking priority review of this application, as we believe physicians and their patients are in need of new therapies to address OIC that may not affect opioid analgesia. If approved, this would be the third indication for the lubiprostone franchise and allow more patients access to this medicine.”
Opioid-induced constipation is one of the most common side effects of opioid-based medicines, which are used in the management of chronic pain. OIC affects the majority of patients treated chronically with opioids. Some patients discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.
“This submission is an important milestone for both companies,” said Charlie Baum, Vice President, U.S. Medical Affairs, Takeda. “It is critical that we continue to identify and respond to unmet needs of patients with constipation, including OIC.”
AMITIZA (lubiprostone) is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (24 mcg twice daily) in adults and for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older by the FDA in the United States. AMITIZA (lubiprostone) is approved in Japan for the treatment of chronic constipation (excluding constipation caused by organic diseases) and in Switzerland for chronic idiopathic constipation.