Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

In the last SequestOx trial, the company also ran a new non-pharmacologic ADF oxycodone formulation. The new formulation was described as a "physical" ADF, meaning it is a hard-shell that resists crushing and cannot be hydrated for a syringe. These are PEG-based formulations that do not contain naltrexone. This kind of hard-shell ADF could be used to make an ADF version of Adderall or any other CNS stimulant.

These hard shell ADF's are fine, not great, but fine. They are all made with compressed polyethylene glycol (PEG). They generally do a pretty good job at making it more difficult to snort, smoke, or inject opioids. Not impossible but much more difficult. I assume they would do pretty much the same thing for stimulants like Adderall. They do nothing to prevent oral abuse, and the FDA team is often able to identify multiple ways to defeat them, which they usually discuss in a separate private session of an AdCom meeting.

There are several important problems with PEG-based hard shell ADFs. First is the Opana debacle was caused by the PEG. Whatever formula they used for their cross-linking was wrong and it resulted in an ADF formulation that was very injectable. Not only that, but abusers would use steel wool to catch all the nasty PEG particulates, and it turns out that steel wool is a highly effective medium for transmitting HIV and Hep C. It was a disaster in multiple areas of the country, and it was all because of incorrect PEG cross-linking.

Also, compressed PEG ADF is patented, but not by Elite. Just about every OxyContin patent infringement lawsuit by Purdue was based on the PEG composition of the hard shell. There could be a risk of patent infringement suit for any drug using a compressed PEG hard shell as an ADF.