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Outcomes of the Pediatric Development Plan of Tapentadol

Mariëlle Eerdekens1, Tatjana Radic1, Melanie Sohns1

  • 1Grünenthal GmbH, Aachen, Germany.

Journal of Pain Research
|February 5, 2021
PubMed

Insights

Tapentadol, an opioid analgesic, is the first pain medication formally developed for pediatric patients. Its oral solution was approved in the EU for moderate to severe acute pain in children aged 2 to 18.

Area of Science:

  • Pediatric pharmacology
  • Pain management
  • Regulatory science

Background:

  • Tapentadol is an opioid analgesic used for pain relief.
  • Formal regulatory pathways for pediatric drug development are crucial.
  • Pediatric pain management requires age-appropriate formulations and dosing.

Purpose of the Study:

  • To summarize the outcomes of the tapentadol pediatric development program.
  • To discuss challenges in pediatric clinical trial design and execution.
  • To outline interactions with regulatory authorities during development.

Main Methods:

  • Review of the pediatric development program for tapentadol.
  • Analysis of clinical trial data across neonates to adolescents.
  • Examination of regulatory interactions and challenges.

Main Results:

  • Tapentadol oral solution authorized in the EU in 2018.
  • Indicated for moderate to severe acute pain in children aged 2 to <18 years.
  • Development addressed the full pediatric age range from birth.

Conclusions:

  • Tapentadol represents a significant advancement in pediatric pain management.
  • The formal development process facilitated regulatory approval.
  • Further insights into pediatric clinical trial conduct and regulatory engagement are provided.

Keywords:
painpediatricregulationsreviewtapentadol

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