Citizen Petition Seeks Limited Opioid Drug Indication To Curb Overuse And Abuse
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.
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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.
FDA tells sponsors to revise the indication for the ER/LA analgesics to highlight appropriate patient selection rather than severity of pain and orders post-marketing studies to identify a dose and duration-of-treatment associated with higher rates of abuse, misuse, addiction, overdose and death.
Purdue epidemiological studies indicate reformulation of OxyContin had a positive effect on abuse and misuse of the drug, but the company says continued monitoring is needed to assess whether the positive trend continues.