Joint Advisory Committee Splits on One Opioid, Rejects Another

Two FDA advisory committees considered two new opioid analgesics, shooting down one and deadlocking on another. 

The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 24-2 not to recommend approval of Intellipharmaceutics’s abuse- deterrent opioid Aximris XR (oxycodone extended-release tablets), finding that the risks outweigh the benefits.

If approved, Aximris XR would be the first opioid analgesic with intravenous abuse-deterrent properties. However, the committee did not think that the property of IV abuse deterrence was worth the risk of abuse through other methods.

Kevin Zacharoff, course director for pain and addiction at the State University of New York, who voted in favor of the drug, called it “an incremental step in the right direction” to deter intravenous abuse.

The joint panel also deadlocked on Esteve Pharmaceutical’s E-58425 (tramadol 44mg and celecoxib 56mg), conflicting on whether or not there was enough data to prove its superiority over its separate ingredients.