Sucampo Pharmaceuticals, Inc. commenced a global pivotal phase III study for Amitiza in pediatric functional constipation.
The phase III program has two similar designed well-controlled pivotal studies. The first part of the study, which has already commenced, is a randomized, placebo-controlled, double-blind study which evaluates the efficacy, safety and pharmacokinetics of Amitiza in pediatric patients aged 6 to 17 years. The other part will evaluate Amitiza liquid formulation in patients aged 6 months to below 6 years.
The first part will enroll more than 500 pediatric functional constipation patients which will be treated for 12 weeks with weight-based dosages of 12 mcg or 24 mcg twice daily (BID). The primary endpoint of the study is the overall spontaneous bowel movement (SBM) response.
The long-term safety of Amitiza will also be evaluated in two open-label extension studies. Sucampo notes that functional constipation has seen an approximately 300% rise in the U.S. over the last 10 years. A supplemental new drug application (sNDA) is expected to be filed with the U.S. Food and Drug Administration (FDA) by early2016.
We note that Amitiza was approved by the FDA in 2006 for chronic idiopathic constipation (CIC) in adults. Then, it gained FDA approval in 2008 for irritable bowel syndrome with constipation (IBS-C) in women aged above 18 years. Furthermore, it gained FDA approval for opioid-induced constipation (OIC) in Apr 2013. Amitiza is approved for CIC in Switzerland as well as the UK and for chronic constipation (CC) in Japan.
Sucampo carries a Zacks Rank #1 (Strong Buy). Some equally ranked stocks include Questcor Pharmaceuticals Inc. , Actelion Ltd. and Jazz Pharmaceuticals plc (JAZZ - Free Report) , each carrying a Zacks Rank #1 (Strong Buy).