Navigation Links
Digestive Care, Inc. Announces FDA Approval of PERTZYE™ (pancrelipase) Delayed-Release Capsules

BETHLEHEM, Pa., May 18, 2012 /PRNewswire/ -- Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for PERTZYE™, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) 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 well-being 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).  For complete safety information, warnings, precautions and limitations of use for PERTZYE, please see the full Prescribing Information and Medication Guide available at

"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

About Digestive Care, Inc.

DCI is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders.  For further information, please visit us at


1. MW Konstan, SD Strausbaugh, RC Ahrens, FJ Accurso, GR Graff, SZ Nasr.  Pediatric Pulmonology Suppl 31:425, 2008.

SOURCE Digestive Care, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Boston Scientific Endoscopy Presents Promising Clinical Data During Digestive Disease Week ®
2. Receptos to Deliver Scientific Presentation at Digestive Disease Week 2012 about the Therapeutic Role of RPC1063 in Inflammatory Bowel Disease
3. UCB Proudly Reinforces Long-Standing Commitment to Crohns Disease Community at Digestive Disease Week 2012
4. Groundbreaking Treatments, Innovative Prevention Strategies and New Insights on Impact of Lifestyle Factors on Digestive Health Presented at the American College of Gastroenterologys 76th Annual Meeting
5. Data Presented at Digestive Disease Week Highlights Additional Analysis of DIFICID™ Phase 3 Data
6. Voices of UC Survey Shows Need for Patients with Ulcerative Colitis to Speak Up about Debilitating Digestive Disease
7. WellSpring Pharmaceutical, American Gastroenterological Association, and Steven Bramson of Humanscale Partner With MediaPlanet to Publish One of the Largest Digestive Wellness Campaigns in U.S. History to Overcome Upset Stomach, Nausea, IBS, and Deb
8. Reportlinker Adds IP Overview - "Monoclonal Antibodies against digestive system cancers" Patent Landscape 2010
9. ChemoCentryx Reports that Traficet-EN Maintains Remission in Crohns Disease at the Digestive Disease Week (DDW) 2010 Conference
10. Lexicon to Present Phase 2 Clinical Data for IBS Drug Candidate at Digestive Disease Week
11. Kristalose(R) Clinical Data to Be Presented at Digestive Disease Week(R) Meeting
Post Your Comments:
(Date:11/25/2015)... -- Henry Schein, Inc., the world,s largest provider of health ... animal health practitioners, will unveil at the Greater New ... Pavilion , which brings together for the first time ... help any practice or laboratory enter the digital age. ... of experts appearing at the Pavilion. --> ...
(Date:11/25/2015)... -- Allergan plc (NYSE: AGN ), a ... start-up  biotechnology company focused on the development of ... by the F-Prime Biomedical Research Initiative (FBRI), today ... collaboration to support the discovery and development of ... Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... , Nov. 25, 2015 /PRNewswire/ ... "Company") (NYSE: MR ), a ... medical devices worldwide, today announced that ... general meeting of shareholders at the ... Grand Century, 193 Prince Edward West Road, ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of ... patients are aware of the benefits of Botox® in the treatment of moderate facial ... discomfort, soreness, and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, ...
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a ... sleep tracking systems. The new app features a more intuitive SleepScore™ that rates sleep ... well you slept. The SleepScore is created by a proprietary algorithm. Beddit analyzes the ...
(Date:11/25/2015)... MI (PRWEB) , ... November 25, 2015 , ... In ... Presence Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy ... medical and surgical intensive care units (totaling 30 beds) from May 2014 through October ...
(Date:11/25/2015)... ... , ... Today, Mothers Against Drunk Driving (MADD) learned that the ... the first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol ... National Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in ...
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
Breaking Medicine News(10 mins):