In late 2013, the U.S. Food and Drug Administration approved a new prescription opioid medication, called Zohydro ER, as a treatment for people affected by certain forms of chronic, severe pain. This approval came over the clear objections of the in-house FDA advisory panel responsible for reviewing and considering the medication’s pros and cons. Zohydro ER will enter the U.S. market in March 2014. Numerous critics, including addiction specialists and attorneys general from more than half of all U.S. states, have spoken out against the medication’s imminent release. These critics cite concerns over Zohydro ER’s potential to increase opioid abuse and addiction rates and boost the number of fatal opioid overdoses.
Zohydro ER contains a powerful opioid painkiller called hydrocodone. Other medications currently available in the U.S. that also contain this painkiller include Vicodin, Lortab and Lorcet. Without exception, these previously approved medications combine hydrocodone with a less powerful, non-opioid pain reliever such as acetaminophen or aspirin. However, Zohydro ER only contains hydrocodone (in a form called hydrocodone bitartrate). In addition, since it’s an extended release product designed to supply a continual pain-relieving effect over a fairly long timespan, Zohydro ER contains much more hydrocodone than other available medications. In fact, the highest-strength version of the new medication (50 mg in one capsule) contains five to 10 times as much hydrocodone as standard strength Vicodin.
In December 2012, the FDA advisory panel that makes recommendations on the approval of opioid medications rejected Zohydro ER as a new treatment option. Unlike some votes for medication approval, which include nearly equal numbers of critics and supporters, the vote against the approval of Zohydro ER was a notably lopsided 2-11 (with an additional panel member abstaining). In making its recommendation for rejection, the panel specifically noted the medication’s unusually strong potential for triggering diagnosable cases of both opioid abuse and opioid addiction.
In October 2013, the FDA overrode the recommendation of its own advisory panel and approved the release of Zohydro ER. In support of this decision, the agency concluded that the benefits of this medication for the relief of chronic, severe pain outweigh any potential risks for abuse, addiction or overdose in properly supervised users. In addition, the FDA noted a larger trend in the classification of high-potency opioid medications that moves these substances from a group of drugs and medications called Schedule III controlled substances to Schedule II. Under federal law, Schedule II substances are more heavily restricted than Schedule III substances. Zohydro will enter the U.S. market as a Schedule II medication, and doctors can only legally prescribe it under the tight guidelines established for substances in this class.
Risks for Abuse, Addiction and Overdose
Critics of Zohydro ER approval cite several reasons for their objection to the medication’s entry into the U.S. market. First, they note the high hydrocodone content of the medication. When used properly, Zohydro ER will only release relatively small amounts of this powerful opioid at any given point in time. However, if a prescription user or a person without a prescription crushes a tablet of the medication, he or she can circumvent its extended-release safeguards and gain access to as much as a 50 mg immediately available dose of hydrocodone. In a manner similar to OxyContin, a well-known target of opioid abuse that contains another powerful painkiller called oxycodone, opioid abusers may start to preferentially target Zohydro ER for its hydrocodone content. In turn, largely due to the amount of hydrocodone contained in the medication, opioid abusers who target Zohydro ER may have increased risks for developing an opioid addiction.
Critics of Zohydro ER also note the medication’s potential to produce non-fatal and fatal opioid overdoses. In fact, guidelines issued for Zohydro acknowledge the very real possibility that a single 50 mg dose of the medication could contain enough hydrocodone to kill a child or a new prescription opioid user unaccustomed to the effects of opioid substances. In addition, critics of the medication’s approval believe that Zohydro ER offers no unique treatment benefits to offset its risks. Instead, they note the availability of other currently marketed prescription opioids that can relieve chronic pain without the same level of abuse-, addiction- and overdose-related danger.
The manufacturers of Zohydro ER believe that they can produce tamper-resistant forms of the medication that reduce the risks for abuse and addiction. In late 2013 and early 2014, a diverse group including addiction specialists, consumer protection organizations and attorneys general from 28 states undertook efforts to get the FDA to reconsider its approval for the medication.