The US Food & Drug Administration’s new “public health” framework for considering opioid analgesic applications made its debut in a series of advisory committee meetings in mid-January – and it did not go well for the sponsors.
Two of the three opioid formulations reviewed – Nektar Therapeutics’s new molecular entity oxycodegol and Intellipharmaceutics International Inc.’ proposed abuse-deterrent formulation of oxycodone – were overwhelmingly rejected. In Nektar’s case, the 27-0 “no” vote was so clear that the company didn’t let the day end without announcing the withdrawal of the application and abandonment of the project
