any news today?, page-8

Looks like it will all come down to whether or not the Advisory Committee panel and the FDA view the purported reductions in deep oxygen desaturations (i.e. SpO2 < 80%) as enough of a safety advantage to approve Moxduo, especially in light of the fact that Moxduo results in a higher frequency of shallow oxygen desaturations (80% < SpO2 < 90%).

In terms of how much of a safety advantage may be deemed sufficient, the QRx briefing materials note:

"After discussion at various levels within the Agency, the FDA agreed that QRx could satisfy the Combination Rule by demonstrating, in Study 022, evidence for a safety benefit of Moxduo relative to comparable doses of morphine and oxycodone through post hoc safety analyses. The FDA also stated that this benefit need not be to a level of that needed for a label claim."

In support of this, they quote the following correspondence from the FDA, dated 31/10/2012:

“If review of your arguments regarding a safety advantage were considered robust by DAAAP, this could potentially lead to approval without the level of evidence necessary for a comparative claim within the Indications and Usage section.”

I guess we will know soon enough.