Amitiza lubiprostone regulatory update

The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) approved Sucampo's Amitiza lubiprostone to treat chronic idiopathic constipation (CIC) and associated symptoms in adults when diet and other non-pharmacological measures are inappropriate. Sucampo did disclose when it plans to launch the drug, but said it plans to submit regulatory applications in other EU countries for CIC under the EU mutual recognition procedure, with the U.K. acting as the reference state.

Sucampo also plans to submit regulatory applications in the U.K. and Switzerland for the functional fatty acid chloride channel activator to treat opioid-induced constipation (OIC) by year end. Amitiza is already under review for OIC in patients with chronic, non-cancer pain in the U.S., where Sucampo and Takeda market the product for CIC and irritable bowel syndrome with constipation (IBS-C). ...