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Thursday, October 30, 2014

DEA Proposes Rescheduling Naloxegol

There have been several changes made to drug policy this year; perhaps the most important being the Drug Enforcement Administration’s (DEA) reclassification of hydrocodone combination products, such as Vicodin, to Schedule II. Reclassifying such drugs will hopefully reduce prescription drug abuse, by only allowing patients to receive the drugs for up to 90 days without receiving a new prescription.

Under the Controlled Substances Act, many of Schedule II drugs, both legal and illegal, can be derived from opium alkaloids; drugs such as oxycodone, hydrocodone and heroin are the most commonly abused. Powerful illegal narcotics like methamphetamine, as well as legal Adderall and Ritalin, are also considered Schedule II drugs. People caught illegally dealing or possessing Schedule II drugs face criminal penalties.

However, some believe that there are drugs that have been misclassified as Schedule II, such as the opiate-based painkiller naloxegol, according to The Hill. The Obama administration is proposing that naloxegol be removed from the federal drug schedule, citing research finding the medication “does not possess abuse or dependence potential.”

This fall, the Food and Drug Administration (FDA) approved naloxegol (Movantik) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. Naloxegol’s manufacturer, AstraZeneca, submitted a petition seeking its removal from the Schedule II classification on grounds that the drug, prescribed for non-cancer chronic pain, is not prone to abuse. The DEA agreed with AstraZeneca’s findings that the drug does not meet Schedule II classification requirements.

A recommendation by the Department of Health and Human Services, and the DEA’s own analysis, the agency is now proposing to delist the drug.

“The DEA finds that these facts and all relevant data demonstrate that naloxegol does not possess abuse or dependence potential,” the DEA said. “Accordingly, the DEA finds that naloxegol does not meet the requirements for inclusion in any schedule, and should be removed from control under the CSA.”

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