Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of their supplemental new drug application (sNDA) filing. The sNDA was filed in late July seeking approval for an additional indication for AMITIZA
(lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
The FDA’s priority review, which allows for an abbreviated review period of six months, is granted to drugs that offer either significant advances in treatment or provide a treatment where there is no existing adequate therapy. As a result of this priority review, Sucampo and Takeda expect the FDA’s decision by late January 2013.
“One of the most common adverse reactions of opioid medications is opioid-induced constipation, a medical condition for which there are currently no approved oral prescription treatment options available,” said Dr. Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Scientific Officer, and Chief Executive Officer. “The priority review of this sNDA application underscores that the management of OIC is an unmet need of patients with chronic pain and highlights the need for new therapies to address this condition.”
AMITIZA (lubiprostone) is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) (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); in Switzerland for CIC; and in the United Kingdom for CIC.
Important Safety Information
AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.