Eurand Pharmaceuticals, a subsidiary of specialty pharmaceutical company Eurand, has announced additional data from a post-hoc analysis of a Phase III clinical trial with Zenpep delayed-release capsules, an FDA-approved pancreatic enzyme product, or PEP, for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions.

The study results have reportedly demonstrated that patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) can be transitioned effectively from their previous PEPs to FDA-approved Zenpep. Results from a post-hoc analysis of a Phase III randomized, double-blind, placebo-controlled crossover study in 34 patients with EPI due to CF have showed that patients experienced a significant and rapid symptom improvement when switched from their previous PEP to Zenpep at a comparable daily dose, the company said.

Ruth Thieroff-Ekerdt, chief medical officer of Eurand Pharmaceuticals, 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.”

Source: Datamonitor Newswire

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