Eurand Initiates Phase 3 Clinical Trials for Pancreatic Enzyme Product

Strategic Insights -

Eurand, a specialty pharmaceutical company, has initiated the first of two Phase 3 clinical trials for its pancreatic enzyme product (PEP), EUR-1008M, in patients with exocrine pancreatic insufficiency (EPI). The trial aims to determine the safety and tolerability of EUR-1008M, a new and proprietary PEP developed by Eurand, and compare its effectiveness to placebo in improving absorption of fat and other nutrients. The trial will be conducted in approximately 20 clinical study sites in the United States and is expected to be completed by the end of June 2006, with results expected in the fourth quarter of the same year.

Key Takeaways:

  • EUR-1008M is a new pancreatic enzyme product developed by Eurand, intended to treat malabsorption of fats, proteins, carbohydrates, and other essential nutrients in patients with pancreatic insufficiency.
  • The Phase 3 trial will be conducted in CF care centers in the United States and will evaluate the safety and efficacy of EUR-1008M compared to placebo in improving coefficient of fat absorption and other endpoints.
  • Approximately 20 clinical study sites in the United States will participate in the trial, with patient enrollment expected to be complete by the end of June 2006.
  • Results of the study are expected in the fourth quarter of 2006.
  • EUR-1008M has been developed as a delayed-release capsule intended to provide consistent product dosing over time, and will be available in multiple dosage strengths to provide flexibility and convenience in dosing.
  • Eurand has a long history of experience in developing and manufacturing pancreatic enzyme products, and EUR-1008M represents a significant advance in the treatment of pancreatic insufficiency.
  • The Cystic Fibrosis Foundation Therapeutic Development Network Coordinating Center has collaborated with Eurand in preparing the protocol for the trial.
  • Additionally, Eurand has announced plans to initiate a Phase 3 trial of EUR-1008M in a pediatric population in the second quarter of 2006.
  • EUR-1008M has been developed to meet the FDA's draft guidelines for pancreatic enzyme products and will be available in a number of dosage forms and strengths to provide consistent product dosing, stability, long-term shelf life, and convenient dosing.

Statistics:

  • Approximately 30,000 children and adults in the United States have cystic fibrosis, a genetic disease affecting the body's ability to produce digestive enzymes.
  • Approximately 90% of cystic fibrosis patients suffer from pancreatic insufficiency, which leads to malabsorption of fats, proteins, carbohydrates, and other essential nutrients.
  • EUR-1008M is a new and proprietary PEP developed by Eurand, with a unique formulation designed to meet the FDA's draft guidelines for pancreatic enzyme products.
  • The trial will involve approximately 20 clinical study sites in the United States.
  • Patient enrollment is expected to be complete by the end of June 2006.
  • Results of the study are expected in the fourth quarter of 2006.

Sources:

  • Eurand ASIA PULSE 03-02 1343
  • Eurand's website at http://www.eurand.com