Purdue Seeks Equity In Abuse/Misuse Labeling For Immediate-Release Opioids
This article was originally published in The Pink Sheet Daily
The manufacturer of extended-release oxycodone contends in a citizen petition that immediate-release and extended-release/long-acting opioid analgesics contain the same active ingredients and pose a similar risk of abuse, misuse and overdose.
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Physician group appeals for FDA to rescind approval for moderate non-cancer pain and Massachusetts Democrat Rep. William Keating introduces legislation that would bar FDA approval of a non-tamper-resistant opioid drug if the same active moiety already was approved in a tamper-resistant product.
If FDA decides to incorporate mandatory prescriber training into a Risk Evaluation and Mitigation Strategy for extended-release opioids, industry implementation options include setting up an industry-wide registry or seeking congressional action to tie training verification into a Drug Enforcement Administration registry
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.