Sucampo Pharmaceuticals, Inc
) Amitiza was approved by the U.S. Food and Drug Administration
(FDA) in 2006 for chronic idiopathic constipation (CIC) in
adults. In 2008, the drug gained FDA approval for irritable bowel
syndrome with constipation (IBS-C) in women aged above 18 years.
In Apr 2013, the FDA cleared Amitiza for opioid-induced
Sucampo and partner
Takeda Pharmaceuticals Inc.
) announced that it has commenced a pivotal study of a liquid
formulation of Amitiza 24 mcg in adults with CIC.
This randomized, placebo-controlled, double-blind,
multi-center study (n=152) will assess the pharmacodynamics,
pharmacokinetics and tolerability of a liquid form of Amitiza in
adults with a confirmed diagnosis of chronic constipation.
Results from the study will be out at the end of 2014. Sucampo
will file a New Drug Application after the review of the
Sucampo also intends to study the liquid formulation of
Amitiza in children as part of its upcoming, global, multicenter,
phase III program to study drug in the pediatric functional
Earlier this month, Sucampo reported encouraging data from a
study (n=127) which demonstrated that Amitiza was effective and
well tolerated in children and adolescents with functional
constipation. The data was published in the
Journal of Pediatric Gastroenterology & Nutrition
. The study had a primary endpoint of spontaneous bowel movements
(SBM) frequency during the first week versus baseline. The mean
SBM frequency climbed to 3.1 SBMs/week from 1.5 SBMs/week at week
Sucampo carries a Zacks Rank #2 (Buy). Currently, companies
Isis Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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