Wednesday, April 01, 2015 9:08:53 AM
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8703186.PN.&OS=PN/8703186&RS=PN/8703186
By using IR highly potent Oxycodone, the FDA is IMO accepting $ELTP 12-ER Acrylic Polymer for their planned ADTs as proven due to $ELTP previous trials for all of their ADTs during 2013/2014. So now the FDA wants grueling proof that $ELTP co-polymer for sequestering the Naltrexone will not leak when exposed to all of the body fluids when taking opioids orally as prescribed.
The 15 mg IR Oxycodone is 30 to 40% more potent than Morphine which would likely require 19 to 21 mg to be equivalent analgesically. By using 15mg IR Oxycodone in the P3 Pain Efficacy ongoing trials with 162 persons, the FDA likely accepts IMO that if the co-acrylic sequestering polymer does not leak than the same non-invasive modular technology for other common agonists such as Morphine will also be successful.
Increasingly I am coming to the conclusion that proving the leak proof stable feature of the co-acrylic sequestering polymer with IR 15mg Oxycodone will also at the same time prove the success of $ELTP's planned Morphine ADT. IMO then it is very possible that both of $ELTP's ADTs Oxycodone and Morphine agonists will be approved by the FDA if the P3 pain efficacy trials are statistically successful.
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