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 (LSS) patients.
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 placebo.
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 opioid-induced constipation.
Sucampo carries a Zacks Rank #1 (Strong Buy). Investors may also consider companies like Enanta Pharmaceuticals, Inc. (ENTA - Free Report) , Jazz Pharmaceuticals (JAZZ - Free Report) and Questcor Pharmaceuticals Inc. , all of which carry a comparable Zacks Rank #1.