One Loss, One Tie: US FDA Panels Prove Difficult For Opioid Sponsors Intellipharmaceutics, Esteve

16 Jan 2020

Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.

FDA Advisory Committee Feature image — A US FDA panel overwhelmingly rejected one opioid formulation but delivered a split verdict on another.

A US Food and Drug Administration panel’s review of two opioid-containing products on 15 January suggests sponsors face a high bar in bringing new formulations to market under the agency’s emerging benefit/risk framework for the category.

The anesthetic and analgesic drug products and drug safety and risk management advisory committees overwhelmingly recommended against approval of