The only ART opioid product that the FDA approved was ALO-01 based on material submitted which was likely R&D Pilot Grade. The FDA then could compare the Commercial Grade Elite Human Pilot Studies BE/PK results vs ALO-01 as regards to delivery for
(1) 12 ER delivery for the opioid agonist ER polymer to (i) relieve pain over 12 hrs (ii) prevent dose dumping
(2) sequestering delivery of the antagonist polymer during (i) normal intake and over 24 to 72 hrs after swallowing (ii)abuse intake and release time to stop all euphoric reaction.
As for ALO-02 the FDA has the option to compare similar Oxycodone/Naltrexone in trial based on current trial data.