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Topic: FDA
May 6, 2014 | Posted By Kathleen O’Connor, MSW, MBA, MS

The governor of Massachusetts placed an emergency ban on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. 

Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The battle began when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. Practioners are recommended to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    

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