In addition, Digestive Care has recently completed a randomized, double-blind, placebo-controlled, multi-center, crossover study on Pancrecarb MS-16. The clinical trial was conducted at five centers and included 21 subjects.
Tibor Sipos, president and chief scientific officer of Digestive Care, said: “Digestive Care has provided vital products used to treat exocrine pancreatic insufficiency for over a decade and we are committed to filing the remaining modules for the new drug application (NDA) for Pancrecarb to meet the April 28, 2009 requirements set forth by the FDA.”