Digestive Care, Inc. (DCI), announced it has received U.S. Food and Drug Administration (FDA) approval of its new drug application for PERTZYE™, indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
PERTZYE is a unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres and is protected by several U.S. and international patents. The PERTZYE formulation was previously marketed by DCI for over a decade under the trade name PANCRECARB® MS-16.
Dr. Tibor Sipos, President and Chief Scientific Officer at DCI, stated, "The approval of PERTZYE represents a significant milestone for DCI. This achievement confirms our commitment to the continued development of products vital to the wellbeing of patients living with chronic diseases."
The short-term safety and efficacy of PERTZYE were evaluated in a randomized, multicenter, double-blind, placebo-controlled, crossover study conducted in patients ages 8 to 43 years with EPI due to CF.1 The primary efficacy endpoint was the mean difference in coefficient of fat absorption (CFA) between PERTZYE and placebo treatment. Mean CFA was 83% with PERTZYE treatment compared to 46% with placebo treatment (p<0.001).
"The improvement in mean CFA observed in the controlled study represents a clinically meaningful treatment benefit for patients using PERTZYE. Availability of this unique buffered formulation of pancreatic enzyme is an important addition to the therapeutic options for CF and other patients with EPI," stated Michael W. Konstan, MD, Chairman of Pediatrics, Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio.
Additional information on the approval of PERTZYE can be found in the FDA Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP) at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204745.htm.