Despite recommendations by its own advisers, the US Food and Drug Administration approved last month a powerful new opioid painkiller without abuse-deterrent ingredients and tested through favorable methods.

In addition, the first hydrocodone-only opioid Zohydro, approved by an FDA panel vote of 11 to 2 in late October, is manufactured by the same company, Alkermes, that makes the popular medication Vivitrol used to treat addiction to painkillers and alcohol.

Alkermes also provides financial support to a powerful professional group of substance abuse experts, the American Society of Addiction Medicine.

Zohydro is set to come in doses that will contain five to 10 more narcotic than established hydrocodone products like Vicodin, which is hydrocodone mixed with everyday painkillers such as acetaminophen or ibuprofen.

Zohydro dosages are designed to be released over a span of 12 hours, but abusers of the drug will be able to crush, chew or mix it with alcohol to release its effects much quicker.

A November 2012 memo from the FDA’s staff warned Zohydro could be abused more than other hydrocodone products, such as extended-release, oxycodone-containing opioids were in previous years, the Milwaukee Journal Sentinel reported.

The most notorious of oxycodones is the oft-abused narcotic Oxycontin. Its maker, Purdue Pharma, recalibrated the pill’s recipe with an abuse deterrent in 2010.

Zohydro, however, will not have to adhere to those same protections, at least not yet. One day before the approval of Zohydro, the FDA tightened rules on hydrocodone products, requiring the same Schedule 2 abuse-deterring restrictions as oxycodone products. Nevertheless, Zohydro received approval as is, despite a recommendation against it by an FDA advisory panel in December.

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Posted by The NON-Conformist