Trying to Stop Zohydro

A new opioid painkiller is set to hit the market, despite objections from doctors, addiction treatment centers and even the advisory panel that tried to stop it. The drug, Zohydro ER, is a pure form of hydrocodone, an opioid that had previously only been available in combination with other drugs like acetaminophen, as it is with Vicodin and Lortab. Critics say the pure drug is not needed and is just another prescription painkiller that is too easy to abuse. Industry leaders have taken the unprecedented step of writing to Dr. Margaret Hamburg, commissioner of the Food & Drug Administration (FDA), to ask her to reverse the decision. In addition to the letter signed by more than 40 leaders in the addiction and healthcare industry, the FDA has heard from state attorneys general and members of Congress asking for further research and a delay. The FDA approved Zohydro in October 2013 in a strange sequence of events. First, the FDA advisory panel had advised against the approval by a vote of 11-2. The FDA is not obliged to follow the panel’s recommendation, but it usually does, and a vote of 11-2 against approval was considered to be a sure thing. Next, the FDA announced that it was recommending that the Drug Enforcement Administration (DEA) change the scheduling of hydrocodone combination drugs like Vicodin and Lortab from schedule III to schedule II, making them more difficult to prescribe.  The following day, the FDA announced the approval of Zohydro, and announced it already would be schedule II. The final piece in the strange puzzle is that Zohydro has no abuse deterrence technology. In 2010, OxyContin had switched to a harder-to-abuse formula, which is difficult to crush and turns to gel when it is dissolved in water. Each of these methods makes the drug harder to snort, smoke or inject. In January 2013, the FDA issued guidelines to companies to help develop drugs that could not be abused as easily. Later the agency announced that such technology would be a requirement but then did not require it for Zohydro. The FDA said Zohydro was well through its development pipeline and was not required to abide by the new guidelines. The FDA has a choice: To allow Zohydro on the market, although with all the concern from doctors, one wonders who will even prescribe it, or reconsider its decision and keep one avenue to prescription drug abuse closed off.