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Paediatric investigation plans for pain: painfully slow!

Elin H Davies1, Cecile M Ollivier, Agnes Saint Raymond

  • 1Institute of Child Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.

European Journal of Clinical Pharmacology
|September 8, 2010
PubMed

Insights

The Paediatric Regulation

Area of Science:

  • Pharmacology
  • Paediatric Medicine
  • Regulatory Science

Background:

  • The Paediatric Regulation, effective January 27, 2007, aims to improve drug development for children.
  • Pain management in paediatric populations presents unique challenges.
  • Limited age-appropriate medications necessitate research into new therapeutic agents.

Purpose of the Study:

  • To assess the initial effects of the Paediatric Regulation on pharmaceutical drug development for pain management.
  • To analyze submissions to the Paediatric Committee (PDCO) and European Medicines Agency (EMA) post-regulation.

Main Methods:

  • Analysis of Paediatric Investigation Plans (PIPs) with decisions issued between September 2007 and March 2010.
  • Review of PIP outcomes, including granted waivers, negative opinions, and withdrawn applications.

Main Results:

  • 17 PIPs were submitted, with 14 receiving an EMA decision.
  • Eight PIPs were granted waivers, indicating limited new drug development for paediatric pain.
  • 15 clinical trials involving at least 1,282 children were planned across five products.

Conclusions:

  • The low number of PIP submissions suggests a deficit in new paediatric pain medication development.
  • Balancing ethical considerations for child participants with the need for approved paediatric treatments is crucial.
  • Collaboration among stakeholders is essential to advance paediatric pain management.
Abstract

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