Sucampo Pharmaceuticals, Inc.’s 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 constipation (OIC).
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 results.
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 constipation indication.
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 1.
Sucampo carries a Zacks Rank #2 (Buy). Currently, companies like Isis Pharmaceuticals, Inc. (ISIS) and Actelion Ltd. look more attractive with a Zacks Rank #1 (Strong Buy).