US Pharm. 2013;38(12):6.Silver Spring, MD—The FDA has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. It is classified as a Schedule II drug and is the first FDA-approved single-entity (not combined with acetaminophen, as in Vicodin) and extended-release hydrocodone product. Despite risks of addiction and abuse, the drug is not being released in a tamper-resistant formula like other available opioids, although it will be monitored as part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). The drug’s manufacturer, Zogenix, is currently developing an abuse-deterrent formulation as well.
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