FDA approves Sucampo's Amitiza

USA-based drugmaker Sucampo Pharmaceuticals says its drug Amitiza (lubiprostone), used in the treatment of chronic, idiopathic constipation in adults, has received approval from the Food and Drug Administration. The drug, which is formulated as a tablet for oral use, is the first selective chloride channel activator approved by the FDA for this indication.

The FDA decision is based on two pivotal, double-blind, placebo-controlled studies which showed that 60% of patients treated with the drug experienced a spontaneous bowel movement within 24 hours. The firm adds that the drug also reduced abdominal bloating, discomfort and constipation severity when administered over the 12 month treatment period.