competition gets ahead of PGNX but why NKTR didn't even move a bit by this?
Sucampo Pharmaceuticals Inc and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) 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.