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The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).1
PHARMACOLOGY — Hydrocodone is a semisynthetic opioid. It is metabolized primarily by CYP3A4-mediated N-demethylation to norhydrocodone and to a lesser extent by CYP2D6-mediated O-demethylation to hydromorphone. Overall hydrocodone exposure is similar after administration of Zohydro ER or comparable daily doses of immediate-release hydrocodone combination products, but... more
2. RL Rauck et al. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study. Pain Med 2014; Feb 12 (epub).
4. FDA Background Material – NDA 202880. Zohydro ER (hydrocodone) for the management of moderate to severe chronic pain. Meeting of the AADPAC, December 7, 2012. Available at www.fda.gov. Accessed May 29, 2014.