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FDA Grants Priority Review Status to Amitiza (Lubiprostone) for Opioid-Induced Constipation
Agency decision expected by late January (Sept. 25)
Sucampo Pharmaceuticals, Inc., based in Bethesda, Md., and Takeda Pharmaceuticals U.S.A., Inc., based in Deerfield, Ill., announced on September 25 that the FDA has granted priority review of a supplemental new drug application (sNDA) filed in late July. The sNDA is seeking approval for an additional indication for Amitiza (lubiprostone) for the treatment of opioid-induced constipation in patients with chronic noncancer pain.
As a result of the priority review, Sucampo and Takeda expect the FDA’s decision by late January 2013.
Amitiza is a chloride-channel activator indicated in the U.S. for the treatment of chronic idiopathic constipation (CIC) (24 mcg twice daily) in adults and for irritable bowel syndrome (IBS) with constipation (8 mcg twice daily) in women 18 years of age and older.
In clinical trials of Amitiza 24 mcg twice daily (n = 1,113) versus placebo (n = 316) in patients with CIC, the most common adverse reactions were nausea (29% vs. 3%), diarrhea (12% vs. <1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distension (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of Amitiza 8 mcg twice daily (n = 1,011) versus placebo (n = 435) in patients with IBS with constipation, the most common adverse reactions were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
For more information, visit the Sucampo Pharmaceuticals, Inc. Web site.