ARTICLE | Regulation
Path to opioid-free pain relief
How clarity on outcomes could spur development of non-opioid analgesics
December 8, 2018 3:14 AM UTC
To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some basic parameters around the idea, it did little to help FDA whittle down the possibilities for opioid-sparing metrics.
On Nov. 15, FDA held a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss opioid-sparing outcomes for acute pain trials. Up for debate were the merits of various outcomes related to opioid sparing and the data needed to support them...