Dataset from Pharmacokinetics of Multiple Dose Methadone in Children

NICHD-2013-MTH01 was a multiple center, open label, prospective PK and safety profile study. The primary objective of this study was to describe the pharmacokinetics (PK) of enteral methadone in children to address gap in pediatric labeling. The PK and safety analyses also include methadone data from NICHD-2011-POP01 (Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care), a multiple center, prospective PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. Safety, demographic, baseline, dosing, and PK variables were summarized separately. Methadone was well-tolerated at the doses studied in this population. There were no AEs related to study drug and all changes in laboratory values were clinically insignificant.