Additional Progress on Reducing Abuse of Opioid Pain Relievers

FDA’s approval of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate) marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. Hysingla ER’s approval provides prescribers with another option for managing pain severe enough to require daily, around-the-clock, long term opioid treatment in patients for whom alternative treatment options are inadequate, while potentially reducing hydrocodone abuse. In pre-approval testing, Hysingla ER exhibited properties that FDA expects will reduce the likelihood users could abuse the drug by chewing the tablet and ingesting it orally, or crushing it into powder for snorting or injecting. This is important because immediate-release combination products containing hydrocodone are among the most frequently abused opioid products. Hysingla ER is the fourth prescription opioid approved with product labeling that is consistent with the FDA’s 2013 guidance on abuse-deterrent opioids. While Hysingla ER has the same active ingredient (hydrocodone) as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two. Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every 24 hours. FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER. Notes Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA, “Prescription opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse problem, but they can be part of a comprehensive approach to combat the epidemic. And the development of abuse-deterrent opioids is only one of many elements of FDA’s overall approach, which includes provider and patient education, close monitoring of approved opioids, and review and approval of drugs to treat addiction and prevent overdose.”
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