Tuesday, October 29, 2013

FDA Approves Long-Acting Extended-Release Hydrocodone Formulation

The Food and Drug Administration  (FDA) yesterday approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Zohydro ER, a Schedule II controlled substance, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain, according to the FDA.

Schedule II drugs can only be dispensed through a physician’s written prescription, and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances.

For more information about how the government sets schedules for classifying opioid medications, see the Psychiatric News article, “AMA Delegates Debate Opioid Rescheduling.” To read about the role of psychiatrists in treating patients with chronic pain, see the article "Psychiatrists' Expertise Useful in Managing Chronic Pain."

Also see the book Clinical Manual of Pain Management in Psychiatry from American Psychiatric Publishing.

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