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.
Jazz Pharmaceuticals plc
), each carrying a Zacks Rank #1 (Strong Buy).
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