Drugs

New Safety Measures Announced for Extended-release and Long-acting Opioids

[5-11-2017] FDA released the original postmarketing requirement (PMR) for some abuse-deterrent (AD) opioids to show that the properties intended to deter misuse and abuse of the product actually result in a meaningful decrease in misuse and abuse, and their related clinical outcomes of addiction, overdose, and death, in post-approval settings. It will be replaced with a two-phased study approach in order to obtain the data needed to fulfill the PMR because the agency has determined that a sequential approach will be more responsive to the uncertainties inherent to this situation – namely, a study that is dependent on adequate uptake of the product in the market.

[2-4-2016] FDA released five postmarketing (PMR) requirements announced on September 13, 2013 and replaced them with eleven PMRs (ten postmarketing studies and one clinical trial) because the ten postmarketing observational studies and one clinical trial include refined measures for assessing the known serious risks of misuse, abuse, addiction, overdose, and death.

[4-16-2014] FDA approved class-wide labeling changes for all extended-release and long-acting (ER/LA) opioid analgesics announced on September 10, 2013, and responded to two petitions regarding labeling for neonatal opioid withdrawal syndrome (NOWS).

[9-10-2013] FDA announced a set of significant measures to enhance the safe and appropriate use of extended-release and long-acting (ER/LA) opioids. These actions include proposed class-wide safety labeling changes and new postmarket requirements for all ER/LA opioid analgesics. FDA also responded to two citizen petitions.

February 4, 2016

September 10, 2013

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