NICE backs Sucampo's Amitiza
The U.K.'s NICE issued a Amitiza lubiprostone from Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP) to treat chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives -- its approved indication. The drug was approved by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) in September 2012 for CIC and associated symptoms in adults when diet and non-pharmacological measures are inappropriate. It has been commercially available in the U.K. since December 2013.
In March, Sucampo received a notice of refusal from MHRA for a Type II variation submission seeking to expand the label of the functional fatty acid chloride channel activator to include the treatment of opioid-induced constipation (OIC) in patients with non-cancer pain. ...