Analgesic Drug Development for Children: A History of Shortcomings … Until Now

Abstract

Andrew Dinh,1 Ardin Berger,1 Elliot Krane1,2 1Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA; 2Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USACorrespondence: Andrew Dinh Email [email protected] With hundreds of pharmaceutical companies internationally, each sharing a portion of a global, multi-trillion dollar business, and with international drug approval regulations varying widely in terms of restrictions, timing, and cost, each decision made by pharmaceutical companies in planning the development of a new drug has immense financial consequences. Grünenthal, a family-owned pharmaceutical company that now employs over 4500 individuals, has funded and executed multiple clinical drug trials of the analgesic tapentadol, a novel molecule with both muopioid and SNRI-like (serotonin and norepinephrine reuptake inhibitor) properties that have been shown to be effective in the treatment of acute and chronic pain in adults. In taking the necessary steps to demonstrate pharmacokinetics, efficacy and, safety in the pediatric population for their drug, Grünenthal has established a precedent and set the bar for other pharmaceutical companies – one that has remained largely absent from the most recent drug releases.