CAansheaderZohydro® is a hydrocodone extended-release (ER) formulation recently approved by the FDA. The approval of Zohydro® has been so controversial that the Governor of Massachusetts attempted to ban the sale of Zohydro® in the state. The cost of Zohydro® ranges from a minimum of $420/Rx (for 10 mg twice daily; #60 capsules) to $514/Rx (for 50 mg twice daily; #60 capsules). Generic hydrocodone/APAP 5/325 mg #120 (dosed four times daily) only costs about $20/Rx. Practice guidelines and published review articles strongly question the value and efficacy of opioids, including hydrocodone, in the management of chronic pain. A brief overview of other issues involving Zohydro® follows:

Consideration #1 – FDA Approval Process/Advisory Committee Recommendations
The FDA medical advisory committee voted 11 to 2 against approving Zohydro®. It is extremely rare for the FDA to go against its own advisory committee, particularly when the vote is so one-sided. In February a group of over 40 healthcare agencies, consumer organizations, and substance-abuse organizations requested that the FDA revoke its approval for Zohydro®.

Consideration #2 – Safety Issues/Drug Abuse, Misuse and Diversion Potential
Zohydro® is an extended-release (ER) formulation of hydrocodone for twice daily use. The ER capsule is available in the following Hydrocodone concentrations: 10, 15, 20, 30, 40 & 50mg. Previously the highest hydrocodone dose on the market was a 10 mg immediate-release formulation combined with acetaminophen (e.g., Lortab®, Norco®, and Vicodin®). Zohydro® does not incorporate any drug abuse-deterrent properties within its dosage form. The DEA has reported that simply opening Zohydro® capsules and crushing the beads can result in one getting over 95% of the entire hydrocodone dose at once, which could result in drug overdose and death. In fact, in trials provided to the FDA, there was a death related to a patient hoarding Zohydro®, opening the capsules and ingesting all of the medication at once.

Consideration #3 – Efficacy Concerns with Chronic Use
While opioids are reasonable therapies in acute/short-term pain management, there is highly limited evidence to support their use in chronic pain. Further, if needed, there are numerous generic immediate-release and extendedrelease opioids available that are far preferred to Zohydro® on the basis of safety, efficacy and cost.

Recommendations from ANS Solutions
ANS Solutions strongly recommends that clients:

  • Red Flag any requests for Zohydro
  • Consider conducting a Pharmacotherapy Review as soon as a new request for Zohydro® is obtained.
  • It is critical that an intervention occur as soon as possible. Once a patient is stabilized on Zohydro®, or
    particularly in patients who are abusing/misusing Zohydro®, fostering a conversion will be challenging.

Please contact ANS Solutions with any questions about Zohydro®.

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