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Re: dr_lowenstein post# 177042

Sunday, 01/03/2016 6:55:26 PM

Sunday, January 03, 2016 6:55:26 PM

Post# of 414338
Hardly nonsense. $ELTP R&D developed the SOP manufacturing details for EPIC's FDA approved IR Roxicodone ANDA and knew the full potency impact.

Surgery patients are often given IR and then ER opioids to alleviate their pain quickly and then continuously. The FDA wanted to know if $ELTP's Naltrexone Sequestered Bead would withstand the high impact of IR Oxycodone and its metabolites. Bunionectomy is an extremely painful surgery cutting thru nerve networks located on the foot.

$ELTP's Sequestered Naltrexone Bead held perfectly allowing the IR Oxycodone to relieve the patient's pain.

For example EPIC's FDA approved IR Roxicodone ANDA, 30mg Oxycodone if given every 6 Hrs would be 120mg over 24 Hrs and 240mg over 48 hrs.






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