Thats the one. February, not January as i had remembered. This...

Thats the one. February, not January as i had remembered.

This meeting is limited to discussions around treating chronic pain, which is treated mostly by CR and not IR opioids, so impact to MoxDuo IR is limited.

But the outcomes from this meeting will bring us one step closer to knowing the FDA's policy approach to approval of opioids in the future.

The FDA approved REMS for ER opioids last year in an effort to address opioid abuse. They are now being asked to go a few steps further and do things like mandate abuse deterrents and reconsider opioid indications and labeling. Very interesting, scientists dont really like being told what do to by bureaucrats...

The FDA's decision on Zohydro's non-abuse deterrent ER generic opioid ANDA (PDUFA March 1) will be the first indicator of how they are going to play this.

There is currently no discussion regarding abuse deterrents for IR opioids like MoxDuo IR, though the STOPP act does give them the power to enforce it. Anyway, perhaps any change that restricts the approval or distribution of ER products will have a positive effect on the size of the IR market, which would be good for QRX. This will take years to play out i suspect.