Evaluating the stability of opioid efficacy over 12 months in patients with chronic noncancer pain who initially demonstrate benefit from extended release oxycodone or hydrocodone: harmonization of Food and Drug Administration patient-level drug safety study data.

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"This work was funded by FDA-BAA-17-00123 HHSF223201710131C. The article was written solely by the authors but was reviewed by the Office of Neuroscience—Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) at the Food and Drug Administration for confidentiality issues and to provide feedback on the clarity of manuscript. J.T. Farrar was the principal author. W.B. Bilker was the principal statistician, and P.T. Cochetti was the data analyst. All three had direct access to the FDA DAARTS and all available data. Drs. Charles E Argoff, Ian Gilron, Jennifer Haythornthwaite, and Nathaniel P. Katz served as primary consultants on the analysis from the outset of the project with input at multiple time points, and each thoroughly reviewed and commented on the article. The study results have been presented to the FDA had been submitted for presentation at the International Association for the Study of Pain in 2020 in Amsterdam which was cancelled."