SPECIAL REPORT

FDA seeks input on postmarketing ER/LA opioid trials

Last fall in light of the prescription opioid abuse epidemic, FDA informed pharmaceutical companies that make opioids that they would be required to conduct postmarketing studies of extended-release/long-acting (ER/LA) opioid analgesics. FDA explained that more data are needed on misuse, abuse, hyperalgesia, addiction, overdose, and death with these formulations.

There are limited data on long-term use of ER/LA opioid analgesics in part because it is difficult to ensure patients' participation in trials longer than 12 weeks.

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• Federal judge blocks Massachusetts Zohydro ban

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