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U.S. Department of Health and Human Services

Drugs

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FDA Provides Facts About Zohydro

[04-30-2014] FDA has prepared this fact sheet to answer the many questions we have received about the drug Zohydro.


 

About FDA’s Approval of Zohydro ER

  • Zohydro ER (hydrocodone bitartrate) is a new treatment option for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatments options are inadequate. This type of debilitating pain negatively impacts patients' ability to live normal daily lives.
  • As a single-entity hydrocodone, Zohydro ER can be taken without the threat of severe liver damage, which can occur with hydrocodone combination products that contain acetaminophen.
  • The FDA makes its approval decisions based on science and by carefully evaluating the safety and effectiveness of every pain medication. In the case of Zohydro ER, we determined that the benefits of the product outweigh its risks.
  • Hydrocodone is a Schedule II opioid analgesic with abuse risk similar to other drugs in its class, the Extended-Release/Long-Acting Opioid Analgesics. It is therefore subject to certain controls including a requirement that patients have a written prescription from their doctor instead of one provided to the pharmacist over the phone (other than in emergency situations, in which case the prescriber must follow up an oral prescription with a written prescription to the dispensing pharmacist within 7 days), and the prohibition of refills.
  • Zohydro ER is the first ER/LA opioid analgesic to include the new safety labeling changes now required for all of the drugs in its class. These include a revised indication designed to enable a more careful and thorough approach to determining whether the drug should be prescribed for a particular patient as well as additional, more pointed, warnings regarding the potential for abuse, misuse, and addiction.  The new safety labeling changes also include the need for prescribers to assess individual patient risk before prescribing the medication and to monitor and follow up with patients. These labeling changes were required to balance the public health risks associated with abuse and misuse while maintaining access to these important medications for those who are in need of them.
  • Zohydro ER is subject to the ER/LA Opioid Analgesic REMS (Risk Evaluation and Management Strategy), which requires that manufacturers make training available to those who prescribe ER/LA opioids and to distribute an updated Medication Guide with each prescription filled.
  • As part of the REMS, companies will report periodically on actions taken to implement the REMS, including the number of prescribers trained and other relevant information. If FDA determines that the REMS is not meeting its goals, the Agency will re-evaluate the program.
  • Like all other sponsors of ER/LA opioids, Zohydro’s sponsor, Zogenix, must conduct post-market studies to assess the risks of misuse, abuse, addiction, overdose, and death associated with long-term use of the product. This information will be used to further inform FDA’s benefit-risk assessment of Zohydro ER and other ER/LA Opioids.
  • We expect that many of the patients prescribed Zohydro ER will be those who are already prescribed an opioid – either extended-release or immediate-release.  So, rather than increase the number of patients treated with opioids, Zohydro ER represents another choice for prescribers. Therefore, we anticipate Zohydro ER will, for the most part, take a slice of the market away from other opioids.
  • FDA intends to monitor the utilization of all opioids to identify any emerging abuse issues.

 

Correcting Misinformation about Zohydro ER

  • There have been many misperceptions about the potency of Zohydro ER in the press. 
    • Zohydro ER is available in strengths ranging from 10 mg to 50 mg of hydrocodone and designed to be released over a 12-hour period.  While this is a larger amount of hydrocodone compared to most immediate-release hydrocodone combination products (strengths ranging from 2.5 mg to 10 mg of hydrocodone), Zohydro ER is in fact less potent than certain strengths of other currently marketed ER/LA opioids such as morphine sulfate, hydromorphone, oxymorphone, and oxycodone.
    • In addition, it is misleading to say that Zohydro ER is stronger than anything currently on the market.  While Zohydro ER has a higher available strength compared to immediate-release products with the same active ingredient, Zohydro ER can deliver the same amount of medication per day with fewer doses (e.g., two doses of Zohydro ER compared to 4 to 6 doses for immediate-release products with the same active ingredient).
  • There has also been misinformation about the development of opioid analgesics with abuse-deterrent properties. Development of abuse-deterrent technologies is a priority for FDA, and we are strongly encouraging companies to continue innovating in this area. However, the relevant science is still in its early stages and has not been fully tested in actual market conditions or use.
  • Even the abuse-deterrent properties of Oxycontin, which are described in its labeling, are limited.  We expect that people intent on abusing these medications will be able to circumvent many of the abuse-deterrent formulations currently on the market or in development. For example, the abuse-deterrent properties of Oxycontin do not prevent addiction; do not prevent oral abuse, which is the most common form of abuse for opioid analgesics; and will not prevent addiction or overdose in people who take too much orally.
  • Abuse-deterrent Oxycontin does not meet the medical needs of all people in severe pain.  We are encouraging development of other opioids with abuse-deterrent features, and development of Oxycontin with more robust abuse-deterrent properties.

 

Summary

  • Both appropriate pain management and the prevention of prescription opioid abuse are top public health priorities at FDA. Actions to advance one should not impede the other; we must balance our efforts and apply sound science as we move forward.
  • FDA shares the concerns about safe and appropriate use of all ER/LA opioid analgesics and the public health consequences associated with misuse and abuse of these drugs.  We believe the steps we have taken for Zohydro ER, including revised labeling with a boxed warning about the known serious risks of addiction, abuse, and misuse (among others), a requirement that manufacturers provide prescriber training, and postmarketing study requirements, will help to support its safe and appropriate use.
  • Our nation’s front-line health professionals – especially physicians and other prescribers – must play a key role and have a responsibility to ensure that they are treating patients based on their individual needs. It is critically important that these health care professionals receive adequate, proper, training and education and that they practice responsible opioid prescribing in order to improve pain management and minimize prescription drug misuse and abuse.
  • The complex public health challenge of opioid abuse and misuse requires a comprehensive and science-based approach involving federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups and industry.