Sucampo Pharmaceuticals, Inc.
) 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
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
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
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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