FDA panel painkiller decision leads toward new approach

Experts suggest tamper-resistant issues get settled first


There is abuse of power and then there is power over abuse and that is what an FDA panel exercised Friday when they recommended against a stronger form of hydrocodone from Zogenix ($ZGNX), citing its potential for illegal use by drug addicts.

An FDA panel of experts voted 11-2 against approval the painkiller Zohydro, which contains 50 mg of hydrocodone, 10 times the dose of Vicodin, Bloomberg reports. The panel said the drug probably would be beneficial to some patients, but suggested the FDA should first consider requiring ways to discourage abuse of opioids–such as methods that make them hard to crush and snort–before approving a more potent version of the drug. The FDA does not have to accept its panel’s recommendations, but usually does.

Drugmaker Zogenix said it understood that point of view but “it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen.”

The FDA told Bloomberg that it is looking into when to require abuse resistant features in opioids. Zogenix is in the early stages of studying a tamper-resistant pill, an official told Bloomberg, as is Purdue Pharmaceutical, the developer of OxyContin. There is also a patent fight that figures in here. Purdue is trying to keep generic versions of OxyContin of the market by arguing that generic makers should have to follow its lead in developing an abuse-resistant version and not be allowed to bring out a generic of the earlier version when its patent expires next year.

– read the Bloomberg story

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