title: Hydrocodone extended-release: pharmacodynamics, pharmacokinetics and behavioral pharmacology of a controversy.
abstract: Recently, the U.S. Food and Drug Administration (FDA) approved Zohydro(®), an extended release formulation of the opioid analgesic hydrocodone that contains no acetaminophen. This approval was against the recommendation of the FDA's Expert Panel. Subsequently, both chronic pain advocates and anti-drug abuse advocates have steadfastly expressed their support of, or astonishment at this decision. Here, we review the pharmacokinetics, pharmacodynamics, safety and abuse liability of this hydrocodone formulation and how it relates to the Expert Panel's opinion and the FDA decision. We discuss the important issues, risk mitigation, potential use of abuse deterrents, and how the different viewpoints of the Expert Panel and FDA decision makers resulted in the approval and subsequent controversy.
authors.affiliation: Department of Neurology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Anesthesiology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Neuroscience Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States; Center of Excellence for Oral and Craniofacial Biology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Alcohol and Drug Abuse Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States.
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Gould
authors.affiliation: Department of Neurology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Anesthesiology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Department of Pharmacology and Experimental Therapeutics, LSU Health Sciences Center, New Orleans, LA 70112, United States; Neuroscience Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States; Center of Excellence for Oral and Craniofacial Biology, LSU Health Sciences Center, New Orleans, LA 70112, United States; Alcohol and Drug Abuse Center of Excellence, LSU Health Sciences Center, New Orleans, LA 70112, United States. Electronic address: dpaul@lsuhsc.edu.
authors.forename: Dennis
authors.initials: D
authors.lastname: Paul
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D010146:Pain / Q000188:drug therapy; D019966:Substance-Related Disorders
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D006853:Hydrocodone
keywords: Abuse deterrents; Abuse liability; Acetaminophen; Hydrocodone; Opioid analgesics; Pain; Pain management; Risk mitigation