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Thursday, July 28, 2016 12:27:16 AM
Sept 10, 2015 FDA comments re Avridi:
• When taken with food
–
Absorption of oxycodone from AVRIDI is substantially delayed.
•
AVRIDI Tmax: Median 4h; Range 1 – 9 h.
•
Roxicodone Tmax: Median 1.5 h; Range 0.5 – 4 h.
–
Oxycodone exposure with AVRIDI is low over 4 – 6 hr compared to Roxicodone
• As demonstrated by substantially lower partial AUC.
–
AVRIDI takes longer to achieve comparable systemic exposurecompared to Roxicodone.
–
Existing IR products do not show delayed Tmax to this extent.
ouch!!!! I would have thought that our A team would have realized they had an issue in Sept, 2015, but.....apparently not
THEY HATE ME CAUSE THEY AINT ME
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