European Journal of Clinical Pharmacology

, Volume 66, Issue 11, pp 1091–1097 | Cite as

Paediatric investigation plans for pain: painfully slow!

  • Elin H. Davies
  • Cecile M. Ollivier
  • Agnes Saint Raymond
Special Article

Abstract

Purpose

To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA).

Methods

Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis.

Results

Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products.

Conclusions

The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain.

Keywords

Paediatric Pain Clinical trials Paediatric regulation Paediatric committee (PDCO) Paediatric Investigation Plan (PIP) 

References

  1. 1.
    Regulation (EC) No. 1901/2006, of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (Official Journal of the European Union L378) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
  2. 2.
    EMA Decisions on paediatric investigation plans (PIPs), including deferrals and waivers, and on modification of an agreed PIP http://www.ema.europa.eu/htms/human/paediatrics/decisions.htm
  3. 3.
    Regnstrom J, Franz Koenig B, Aronsson T, Reimer K, Svendsen S, Tsigkos B, Flamion H-G, Eichler S, Vamvakas ES (2010) Factors associated with success of market authorization applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol 66:39–48CrossRefPubMedGoogle Scholar
  4. 4.
    Committee for Proprietary Medicinal Products (CPMP) Note for guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain, 2003 http://www.ema.europa.eu/pdfs/human/ewp/061200en.pdf
  5. 5.
    Committee for Medicinal Products for Human Use (CHMP) Guideline on Clinical Medicinal Products intended for the Treatment of Neuropathic Pain, 2007 http://www.ema.europa.eu/pdfs/human/ewp/025203enfin.pdf
  6. 6.
    World Health Organization (1987) Cancer pain relief with a guide to opioid availability, 2nd edn. World Health Organization, GenevaGoogle Scholar
  7. 7.
    Lago P, Garetti E, Merazzi D, Pieragostini L, Ancora G, Pirelli A, Bellieni CV; Pain Study Group of the Italian Society of Neonatology (2009) Guidelines for procedural pain in the newborn. Acta Paediatr 98:932–939CrossRefGoogle Scholar
  8. 8.
    Kraemer W, Rose JB (2009) Pharmacologic management of acute pediatric pain. Anesthesiol Clin 27(2):241–268CrossRefPubMedGoogle Scholar
  9. 9.
    Roth-Isigkeit A, Thyen U, Stöven H, Schwarzenberger J, Schmucker P (2005) Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics 2:152–162CrossRefGoogle Scholar
  10. 10.
  11. 11.
    Revised Priority list of off-patent medicines (2009) http://www.ema.europa.eu/htms/human/paediatrics/prioritylist.htm

Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Elin H. Davies
    • 1
  • Cecile M. Ollivier
    • 2
  • Agnes Saint Raymond
    • 3
  1. 1.Institute of Child HealthUniversity College LondonLondonUK
  2. 2.Paediatric MedicinesEuropean Medicines Agency (EMA)LondonUK
  3. 3.Human Medicines Development and EvaluationEuropean Medicines Agency (EMA)LondonUK

Personalised recommendations