Morrisey questions abuse potential of new pain medication - Beckley, Bluefield & Lewisburg News, Weather, Sports

Morrisey questions abuse potential of new hydrocodone-based pain medication

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Attorney General Patrick Morrisey is questioning why the U.S. Food & Drug Administration signed off on Zohydro, a new, extended-release pain medication.

Zohydro ER, the first hydrocodone-only opioid narcotic, is reportedly 10 times more potent than hydrocodone combination drugs, such as Vicodin and Lortab. The FDA approved Zohydro in October and pharmacies began receiving it this month.

Morrisey sent a letter to U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg to express significant concerns over the drug's release. Unlike other name brand and generic opioid-based pain relievers, Zohydro does not contain abuse-deterrent compounds or properties. Morrisey also pointed out West Virginia has one of the highest rates of prescription pill abuse in the nation and leads the country in the number of overdose deaths.

Specifically, Morrisey told Hamburg he'd like to know why FDA ignored the recommendations of its own advisory committee, how the agency evaluated the public health risks associated with the abuse and misuse of Zohydro ER, as well as the factors FDA had considered in deciding to approve Zohydro,

Morrisey also questioned whether the agency had allowed Zohydro ER's manufacturer, Zogenix, to unduly influence it over the approval process, how the FDA views its responsibilities with respect to the substance abuse epidemic and what steps, if any, the agency is taking to mitigate the abuse potential of Zohydro ER.

He also wants to know if FDA is reconsidering its approval of Zohydro ER and requested information about FDA's policy with respect to abuse-deterrent formulations of opioid drug products, criteria the FDA uses to determine when an abuse-deterrent formulation is necessary, why some opioid products are required to have abuse-deterrent formulations while others are not, and, going forward, if the agency expects to approve other opioid products that do not contain abuse-deterrent formulations.

"I am concerned that Zohydro ER may compound the substance abuse epidemic that is already destroying so many lives in West Virginia," Morrisey wrote.

Morrisey said the FDA's decision to approve Zohydro despite previously acknowledging that hydrocodone-based medications have a high potential for abuse raises important questions, suggesting the approval seems to run counter to the FDA's recent push to reclassify some hydrocodone compound medications, such as Vicodin and Lortab, as Schedule II drugs rather than Schedule III. The change in classification would result in tougher prescribing requirements for doctors and eliminate the ability of a patient to get automatic refills on the same prescription.

"I am deeply concerned about the impact of this new medication on the state and her people," Morrisey said. "It is important for us to learn as much as we can about the process that was used to approve the drug and whether there are immediate steps, including the reconsideration of Zohydro's approval, that the FDA can take to protect West Virginians from yet another prescription drug problem."