Zenpep is an FDA-approved pancreatic enzyme product (PEP) used for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
Zenpep has been evaluated in clinical studies in adults and children as young as one year old. Zenpep is offered in four dosage strengths, 5000, 10000, 15000 and 20000 units of lipase, to allow for precise dosing.
Eurand Pharma said that the contents of Zenpep capsules may be opened and sprinkled on soft acidic foods such as apple sauce. This option is an attribute to address the needs of patients who may have difficulty swallowing capsules, such as very young patients or certain older patients.
Eurand Pharma’s Phase III study results showed that patients with EPI due to CF can be transitioned effectively from their previous PEPs to FDA-approved Zenpep. The data of the study was presented at the 33rd European Cystic Fibrosis Society (ECFS) Conference in Valencia, Spain.
Results from a post-hoc analysis of a Phase III randomised, double-blind, placebo-controlled crossover study in 34 patients with EPI due to CF show that patients experienced a rapid symptom improvement when switched from their previous PEP to Zenpep at a comparable daily dose.
Further, Eurand plans to develop ZENPEP for the European market, where the currently marketed PEPs present issues similar to unapproved PEPs in the US In late 2009, the European Medicines Agency (EMA) finalised its draft guidelines on the clinical development and evaluation of medicinal products, including PEPs, for the treatment of cystic fibrosis.
Based on these guidelines and the feedback Eurand received from the EMA on the clinical and regulatory path forward for ZENPEP, the Company anticipates initiating a Phase III study in Europe in the second half of 2010.
Ruth Thieroff-Ekerdt, chief medical officer at Eurand Pharma, said: “These findings come at a critical time for physicians and their patients affected by the FDA’s decision to require manufacturers of unapproved PEPs to cease shipment in accordance with the agency’s April 28, 2010 deadline.
“For those patients who no longer have access to their previously prescribed PEPs, Zenpep has proven clinical safety and effectiveness in the treatment of pancreatic insufficiency due to CF and other diseases.”