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Eurand Initiates Second Phase 3 Clinical Trial for EUR-1008 in Exocrine Pancreatic Insufficiency

Strategic Insights

— 1 min read

Eurand, a specialty pharmaceutical company, has announced the initiation of the second of two Phase 3 clinical trials required for registration of its pancreatic enzyme product, EUR-1008, in patients with exocrine pancreatic insufficiency (EPI). The trial aims to determine the safety and tolerability of EUR-1008 in children under the age of seven. Approximately ten clinical study sites in the United States will participate in the trial, with patient enrollment expected to be complete by the end of the third quarter 2006. Results of the study are expected in the fourth quarter of 2006. The trial has been prepared in collaboration with the Cystic Fibrosis Foundation Therapeutic Development Network.

Key Takeaways:

  • Eurand has initiated the second of two Phase 3 clinical trials for EUR-1008, a pancreatic enzyme product, in patients with exocrine pancreatic insufficiency (EPI).
  • The trial will determine the safety and tolerability of EUR-1008 in children under the age of seven.
  • Approximately ten clinical study sites in the United States will participate in the trial.
  • Patient enrollment is expected to be complete by the end of the third quarter 2006.
  • Results of the study are expected in the fourth quarter of 2006.
  • The trial has been prepared in collaboration with the Cystic Fibrosis Foundation Therapeutic Development Network.
  • EUR-1008 is a new and proprietary pancreatic enzyme product developed by Eurand.
  • The product has been developed as a delayed-release capsule intended to provide consistent product dosing over time.
  • EUR-1008 will be available in multiple dosage strengths to provide flexibility and convenience in dosing.
  • A low dose, micro-tablet formulation has been specifically developed for young children.

Statistics:

  • Ten clinical study sites in the United States will participate in the trial.
  • Patient enrollment is expected to be complete by the end of the third quarter 2006.
  • Results of the study are expected in the fourth quarter of 2006.
  • Approximately 30,000 children and adults in the United States suffer from cystic fibrosis, a genetic disease that can result in pancreatic insufficiency.
  • Approximately 90% of cystic fibrosis patients suffer from pancreatic insufficiency.

Sources:

  • Eurand Contact: Gearoid Faherty (Italy)
  • Eurand Contact: John Fraher (US)
  • Food and Drug Administration (FDA) Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products - Submitting NDAs, April 2006
  • Cystic Fibrosis Foundation Therapeutic Development Network
  • Eurand Website: http://www.eurand.com

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