Sucampo constipation treatment approved by FDA

Amitiza is the first selective chloride channel activator approved for therapeutic use and has been shown to offer effective relief of chronic idiopathic constipation in adults. This condition affects women more often than men and also affects older patients after the age of 65 more frequently.

Amitiza works by increasing fluid secretion and motility in the intestine, and thereby increasing the passage of the stool and alleviating symptoms associated with chronic idiopathic constipation.

The approval is primarily based on data from two pivotal, double-blind, placebo-controlled studies, which showed that approximately 60% of patients who used Amitiza experienced a spontaneous bowel movement within the first 24 hours.

Additionally, the drug was shown to decrease abdominal bloating, abdominal discomfort and constipation severity when administered over the 6-12 month treatment period.

“Amitiza provides an onset of action within 24 hours of administration and can provide relief of symptoms of constipation such as stool consistency and straining,” said Dr John Johanson, clinical associate professor, University of Illinois College of Medicine, and a lead investigator in the trials that lead to the approval for the drug.