No "deterrance" implications in Labels\PIs for any extended release opioid for several years on the market other than what can be deduced through lab results\in vivo per an item issued by the FDA either officially or unofficially.

KG's Embeda and its marketing warning letter in re an outsourced video is a good place to start on what the FDA wants. Even KG's Remoxy discussion on what appears to me with its Oradur(R) technology with oxycodone to be the presently available technology for optimum efficacy\safety; however, the FDA seem to have placed a foolish roadblock by allegedly requiring a stability\rate-limiting lot to be manufactured, a well-known requirement on all pharms before entry "into" any Phase III trials, but, this is still the allegation we are presented by all three management teams involved, DRRX, PTIE, & KG.

I know I haven't even feebly answered your queries as KG appears to have brought all FDA dealings under their control. If you know KG like I know KG, their investor relations is not rated very high.

I personally don't place ACUR's "niacin" platform for its deterrance capabilities at the top of the KG's heap as my spouse takes it quite often for motion-sickness or for atmospheric imbalance or some such problem.


KG's extended release morphine, Embeda, is operating under a temporary REMS as discussed without being directly named in one of the following cites:

http://www.fda.gov/downloads/AdvisoryCom...

http://www.fda.gov/ohrms/dockets/ac/08/b...

Now, wait until Thursday KG CC with audio available and a later printable version on SeekingAlpha just as I quoted from probably available through news item that appears on Yahoo. Don't look for any PPS moving news directly from ACUR on Acurox with KG's Brian Markison in the driver's seat with the FDA and Acurox, IMNO.

I wish I could help more