New Zohydro formula gets FDA's blessing, but abuse-deterrent label has to wait

Since its FDA approval, the all-hydrocodone painkiller Zohydro has sparked outrage from officials and advocates trying to fight the tsunami of opioid addiction. But with its new Zohydro formula now approved, Zogenix ($ZGNX) is hoping it can put out the fire.

The California drugmaker won the FDA's green light for a new formulation using BeadTek, a technology that turns the drug into a viscous gel if it's crushed and dissolved in liquids or solvents. The delivery system doesn't change Zohydro's extended-release properties if it's used as intended, Zogenix says. The company expects to move to the new formula in the second quarter.

"While we are very pleased with the outcomes from our safe use initiatives, implemented with the introduction of Zohydro ER last year, we believe moving forward with this formulation change at the earliest possible time is a responsible action for us to take," company president Stephen Farr said in a statement.

FDA Commissioner Margaret Hamburg

The company is hoping the new formula can silence some of its critics, who last year went as far as to demand FDA Commissioner Margaret Hamburg's resignation over the agency's decision to give the product the go-ahead. Hamburg, for her part, has stood by the approval, noting the limited options for patients in chronic pain.

But it will be awhile before Zogenix can use abuse deterrence as a selling point. Zogenix can't make those claims on the Zohydro label until it submits further data, which it plans to do in the second half of this year, it said.

Meanwhile, though, there's some new competition on the block from opioid maker Purdue Pharma, whose hydrocodone-only Hysingla won approval late last year. And unlike Zohydro, the label on Purdue's product--which launched last week--already sports its abuse-deterrent features.

- read Zogenix's release

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