Sucampo and Takeda Pharmaceuticals announced that the FDA has granted priority review of their supplemental new drug application (sNDA) filing for Amitiza (lubiprostone), seeking approval for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
The sNDA was filed in late July. 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.
Lubiprostone is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) in adults and for irritable bowel syndrome with constipation in women ≥18 years of age.