Intellipharmaceutics International Inc.'s Rexista (oxycodone extended-release) may serve as an early test case for potentially stricter scrutiny from the US FDA – under the leadership of Commissioner Scott Gottlieb – of new abuse-deterrent formulations when the long-acting opioid goes before an advisory committee in late July.
However, even if FDA determines Rexista should be approved with abuse-deterrent labeling, market availability and labeling claims could be delayed for