Amitiza lubiprostone regulatory update

Sucampo said FDA extended by 3 months the PDUFA date for an sNDA for Amitiza lubiprostone to treat opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The new date for the application, which has Priority Review, is in April 2013; it was in January. According to Sucampo, FDA needs more time to review supportive analyses submitted by the company at the agency's request. The agency considered the submission to be a major amendment. Sucampo said FDA did not request additional trials. Sucampo and Takeda market the functional fatty acid chloride channel activator in the U.S. to treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) (see BioCentury, Oct. 1). ...