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.
Takeaways from the meeting will inform four guidance documents FDA is drafting to foster development of non-addictive analgesics. In an Aug. 29 announcement, Commissioner Scott Gottlieb said the agency would release the documents in six to 12 months.
The first guidance will cover opioid-sparing drugs in acute pain. The other three will address risk-benefit analyses for new opioid analgesics, extended-release local anesthetics as alternatives to oral opioids, and non-opioid analgesics for chronic pain.
While half a dozen analgesics have gotten data included on their labels showing they reduce opioid use, the data don’t set a precedent for other companies because the majority of these labels explicitly state that the clinical meaningfulness of the findings is not known (see “Table: Opioid-Sparing Language in Drug Labels”).
FDA has approved at least six products with labels that include data on opioid-sparing activity, but none of the labels make clear the clinical impact of the findings. Moreover, several explicitly state that the clinical relevance of the decreased opioid use has not been demonstrated, which has kept these products from serving as regulatory precedents for new opioid-sparing therapies. None of the products’ trials measured opioid sparing as