Eurand has announced that Eurand Pharmaceuticals Ltd. initiated the rolling submission of its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI). Zentase (formerly EUR-1008), the company's lead product candidate, has been granted fast-track designation by the FDA.
Zentase is a zero-overfill, highly stable, porcine-derived, pancreatic enzyme product (PEP) designed to meet FDA guidelines for PEPs(1). In April, 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.
Pancreatic enzyme products are inherently unstable and thus, to compensate for enzyme degradation over time, all manufacturers currently include an overfill of enzymes in the finished product. As a result, patients receive PEPs with variable and uncertain levels of potency, resulting in inconsistent therapeutic effect. In April 2006, the FDA issued 'Guidance for Industry' addressing the elimination of product overfill allowed under current regulations. As a highly stable product, Zentase does not require overfill and is filled at 100 percent of label claim.
"Zentase is potentially an important advance in treating EPI and may fill a real, unmet need in the marketplace for a consistent, reliable enzyme therapy," said Gearoid Faherty, Chief Executive Officer for Eurand. "In clinical studies, Zentase significantly improved the absorption of fat and protein in EPI patients, while treating the pain and discomfort associated with the disease. Additionally, as a highly-stable enzyme, Zentase provides more consistent and reliable dosing, which may lead to reduced bill burden for patients."
The Zentase NDA filing includes the results of two phase III clinical studies. The studies demonstrate that Zentase showed a clinically relevant increase in the absorption of fat, protein and other nutrients, which is maintained over time. In addition, the studies show that Zentase led to fewer symptoms associated with impaired nutrient absorption such as bloating, flatulence, pain and evidence of fat in stools. Zentase was well tolerated throughout the two clinical studies with no unexpected adverse events.
EPI is a deficiency of digestive enzymes normally produced by the pancreas that can result from a number of diseases, including cystic fibrosis, chronic pancreatitis, and pancreatic cancer. This deficiency of enzymes results in poor digestion and reduced absorption of nutrients, which, if untreated, can lead to impaired growth, impaired immune response and shortened life expectancy.
Treatment with PEPs replaces enzymes lost through this disease. Other than enzyme replacement, no alternative therapy is currently available.
Findings from the clinical trial program will be presented at the upcoming European Cystic Fibrosis Society meeting in Antalya, Turkey.