Sucampo Pharmaceuticals, Inc.
) announced results from a phase IIa proof of concept study for
the evaluation of an intravenously administered compound from the
company's ion channel activator program in lumbar spinal stenosis
This multicenter, randomized, double-blind,
placebo-controlled, dose-escalation study administered patients
with 30 mcg or 60 mcg of the ion channel activator or placebo
twice daily for two weeks. Data from the study revealed that
patients receiving the ion channel activator experienced a
statistically significant improvement in pain as compared to
The study also showed improvements (though not statistically
significant) in the primary and other efficacy measures,
including pain associated with quality of life measures for
patients treated with the ion channel activator.
In this study the ion channel activator was well tolerated. On
the basis of the findings from this study, Sucampo intends to
initiate an additional phase IIa study in 2014 to identify the
apt endpoints and dosing regimen for the compound.
Last week, Sucampo commenced a global, pivotal phase III
program for Amitiza in pediatric functional constipation. The
phase III program comprises two similarly 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 pediatrics aged 6 to 17 years. The
other part will evaluate Amitiza liquid formulation in patients
aged 6 months to below 6 years.
Amitiza was approved by the U.S. Food and Drug Administration
(FDA) for chronic idiopathic constipation in adults, irritable
bowel syndrome with constipation in women aged above 18 years and
Sucampo carries a Zacks Rank #1 (Strong Buy). Investors may
also consider companies like
Enanta Pharmaceuticals, Inc.
, Jazz Pharmaceuticals
Questcor Pharmaceuticals Inc.
), all of which carry a comparable Zacks Rank #1.
ENANTA PHARMA (ENTA): Free Stock Analysis
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SUCAMPO PHARMAC (SCMP): Free Stock Analysis
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