Thoughts on the Latest Long-acting Opioid

Charles E. Argoff, MD


December 31, 2013

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A New Extended-Release Opioid

This is Dr. Charles Argoff, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Management Center at Albany Medical Center in Albany, New York. Today I would like to discuss a clinical scenario that may be common to those of us who take care of individuals with chronic pain, and will also advise those of you who are not aware that a new extended-release (ER) and long-acting opioid preparation has been approved. Using the clinical scenario as a framework, I will discuss this new medication for some of the many people who we take care of who have chronic pain.

Consider a 58-year-old man with chronic low back pain and postoperative knee pain who, as part of his treatment regimen, is receiving hydrocodone 7.5 mg combined with acetaminophen 325 mg 4-6 times daily, which he takes as one component of our treatment approach for his chronic low back pain. Now imagine that a drug that is an ER preparation of hydrocodone, without the acetaminophen, has been approved. Zohydro™ ER is an opioid agonist oral formulation of hydrocodone bitartrate. This drug is indicated for the management of pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The US Food and Drug Administration (FDA) announced this on October 25, 2013, stating that Zohydro ER, a schedule II controlled substance under the Controlled Substance Act, is the first FDA-approved, single-entity ER hydrocodone product. The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks for misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long-term use (beyond 12 weeks). These studies will also be required for other ER and long-acting opioid analgesics.


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