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Outcomes of the Pediatric Development Plan of Tapentadol
Authors Eerdekens M, Radic T, Sohns M, Khalil F, Bulawa B, Elling C
Received 4 November 2020
Accepted for publication 23 December 2020
Published 29 January 2021 Volume 2021:14 Pages 249—261
DOI https://doi.org/10.2147/JPR.S290487
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Michael Schatman
Mariëlle Eerdekens, Tatjana Radic, Melanie Sohns, Feras Khalil, Beata Bulawa, Christian Elling
Grünenthal GmbH, Aachen, Germany
Correspondence: Mariëlle Eerdekens
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
Tel +49 241 569 1090
Email marielle.eerdekens@grunenthal.com
Abstract: The opioid analgesic tapentadol was the first pain medication to be developed for the treatment of pain in children under a formal process established by the regulatory authorities. This article summarizes the outcomes of the pediatric development program for tapentadol across the entire age range from birth (including neonates) to adolescents < 18 years of age. In addition, the challenges experienced when designing and conducting the pediatric tapentadol clinical trials as well as the interactions with the regulatory authorities are discussed. As a first outcome, the oral solution of tapentadol was authorized in the EU in 2018 as a new treatment option in the hospital setting for moderate to severe acute pain in children from 2 to < 18 years of age.
Keywords: pain, pediatric, regulations, tapentadol, review
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