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Release of painkiller Zohydro ER adds to opioid concerns

Release of painkiller Zohydro ER adds to opioid concerns

A powerful opioid painkiller recently released to the market is raising concerns among workers compensation experts as the insurance industry continues to struggle with opioid addiction and abuse among injured workers.

The narcotic makeup of the new drug, hydrocodone bitartrate extended-release capsules under the brand Zohydro ER, could lead to a higher incidence of opioid addiction, some experts fear, though the drug's manufacturer argues that it is no more potent than other opioids on the market.

The release of Zohydro ER comes as workers comp expert debate how to prevent opioid dependence and overdoses among patients receiving narcotic prescriptions long after the immediate aftermath of a severe injury or surgery. A recent release of a separate drug to treat opioid overdoses is seen a useful tool in those efforts (see related story).

“We're seeing a decrease in opioid use, but it's nowhere where it needs to be,” said Brian Carpenter, Tucson, Ariz.-based vice president of pharmacy product at Coventry Workers' Comp Services, a division of Aetna Inc. “We, as an industry, have many patients who are still in the danger zone of taking these types of medications.”

“We're still in the midst of this opioid crisis, and we need to continue to ... give the tools for responsible prescribing and monitoring and patient education,” said Dr. Robert L. Hall, medical director at Progressive Medical Inc., a Westerville, Ohio-based pharmacy benefit manager.

Zohydro ER, approved by the U.S. Food and Drug Administration last year, was released to the market last month. The FDA classifies the extended-release pill, which contains 10 to 50 milligrams of hydrocodone, as a Schedule II controlled substance, meaning it requires a doctor's prescription and refills are not allowed.

The drug already is being prescribed for workers comp patients, said Dr. Teresa Bartlett, Troy, Mich.-based medical director at Sedgwick Claims Management Services Inc.

The average wholesale price of Zohydro ER ranges from $7.02 for the 10 milligram pill to $8.58 for the 50 milligram pill, according to Progressive Medical data.


Experts say Zohydro ER is notable because it is the only pure hydrocodone pill available for sale. Other opioid tablets, such as Vicodin and Vicoprofen, mix hydrocodone with non-narcotic pain relievers, such as acetaminophen and ibuprofen.

By comparison, Vicodin formulations contain 5 to 10 milligrams of hydrocodone mixed with 300 milligrams of acetaminophen, according to North Chicago, Ill.-based drug manufacturer AbbVie Inc.

Medical experts differ about how Zohydro ER's potency compares with other hydrocodone formulations blended with less potent medications, Dr. Hall said.

“One of my concerns is how physicians are going to prescribe this,” Dr. Hall said. “Because if there is a higher potency, they may not understand the dose may need to be decreased.”

Zohydro ER's manufacturer, San Diego-based Zogenix Inc., said in a statement that a “10 (milligram) dose of Zohydro ER is actually the exact same potency as a 10 (milligram) dose of Vicodin or any other hydrocodone product,” and other opioids “are more potent than hydrocodone such as oxymorphone, methadone, hydromorphone and fentanyl.”

Meanwhile, Zogenix has sued to overturn one state's ban on the drug (see related story).

In documents the FDA posted online before Zohydro ER's approval, the agency's staff said it expects Zohydro ER “will be abused, possibly at a rate greater than that of currently available hydrocodone combination products.” While the FDA approved Zohydro ER, its Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2 against releasing Zohydro ER.

Workers comp experts urge caution with the drug, saying it requires safety protocols such as patient monitoring and consultations with physicians to help them prescribe less risky drugs.

“We are doing our best to put (Zohydro ER) through a precertification process and to ensure that physicians have adopted all of the best practices before this is dispensed,” Sedgwick's Dr. Bartlett said.

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