FDA
1st January 1970

Zohydro ER Set to Hit Market This Month, Against Recommendation of FDA Advisory Committee

Given the green light in October, and set to hit the market this month, new opioid painkiller Zohydro ER (manufactured by Zogenix Inc) has been causing quite a controversy. Zohydro ER, a Schedule II controlled substance under the Controlled Substances…

Zohydro ER Set to Hit Market This Month, Against Recommendation of FDA Advisory Committee

Given the green light in October, and set to hit the market this month, new opioid painkiller Zohydro ER (manufactured by Zogenix Inc) has been causing quite a controversy. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Zohydro’s capsules will contain up to 50 mg of pure hydrocodone; this is 5 to 10 times the amount of hydrocodone as Vicodin and without the added acetaminophen. Further, unlike newer versions of OxyContin, this whopping dose of hydrocodone isn’t tamper-resistant. Capsules can easily be crushed, then snorted or injected. This increases the potential of Zohydro ER contributing to the growing epidemic of painkiller addiction. Experts say someone unaccustomed to opioids could overdose with as little as two pills, and that a single pill could kill a child.

Interestingly, Zohydro ER was approved by the FDA against the recommendations of the Anesthetic and Analgesic Drug Products Advisory Committee. In December 2012, the committee voted 11-2 against recommending the drug’s approval. Although the committee noted that Zohydro ER met the Agency standards for efficacy and safety, the committee agreed that standards for opioid product approval should be raised in light of public health concerns of abuse and misuse. The committee stated that the FDA should not approve extended-release opioids without tamper-resistant or abuse-deterrent formulations, and that additional risk mitigation features should be adopted to strengthen the current extended release opioid analgesic risk evaluation and mitigation strategies (REMS). Additionally, the committee members noted that drug diversion and deaths still occurred in clinical trials despite close monitoring, and the frequency of these adverse outcomes would likely be worse in real life clinical practice in the absence of close monitoring.

This may be one of the first times since the 1972 passing of the Federal Advisory Committee Act where the FDA has approved a drug despite a landslide vote to keep it off the market. The approval of Zohydro ER serves as a reminder that the FDA does not always base its decisions on the opinions and votes of its advisory committee panels. Several addiction treatment groups, members of congress, and attorneys general from no less than 25 states are putting pressure on the FDA to reverse the approval of Zohydro ER, arguing the release of it this month will lead to addiction and deadly overdoses. Will the FDA listen to advice from critics and reverse the drug’s approval, or will the FDA leave the drug on the market inviting more criticism and denunciation?

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