Positive Data on Sucampo's Amitiza - Analyst Blog


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Sucampo Pharmaceuticals, Inc. ( SCMP ) announced encouraging data from a study (n=127) which demonstrated that its marketed product Amitiza is effective and well tolerated in children and adolescents with functional constipation. The data was published in the Journal of Pediatric Gastroenterology & Nutrition.

The study evaluated patients aged between 3 and 17 years, weighing at least 12 kgs and having less than 3 spontaneous bowel movements (SBM) in a week on an average. The patients were treated with Amitiza for weeks at doses -12 mcg once daily, 12 mcg twice daily, or 24 mcg twice daily on the basis of their weight and age.

The open-label, multicenter, safety and efficacy study had a primary endpoint of SBM frequency during week 1 vs. baseline. The mean SBM frequency climbed to 3.1 SBMs/week from 1.5 SBMs/week at week 1. Amitiza has also shown statistically significant improvements in SBM frequency from baseline for up to three additional weeks.

Sucampo intends to commence a late-stage clinical development program, consisting of two phase III studies by year end to evaluate Amitiza for the treatment of pediatric functional constipation.   

We note that Amitiza was approved by the U.S. Food and Drug Administration (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 reported $66.7 million U.S. net sales of Amitiza in the second quarter of 2013.

Sucampocarries a Zacks Rank #2 (Buy). Currently, companies like Roche ( RHHBY ), Isis Pharmaceuticals, Inc. ( ISIS ) and Actelion Ltd. ( ALIOF ) look more attractive with a Zacks Rank #1 (Strong Buy).


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SUCAMPO PHARMAC (SCMP): Free Stock Analysis Report

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