Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

pte, collegium DeterX is a unique ADF




It is a physical-barrier ADF, but the capsules can be opened and the microspheres can be dispersed in pudding or apple sauce or put down a gastric tube. Obviously, this would not be possible with any of the other physical barrier ADFs. As far as I know, Elite's capsules can be opened up and the beads could also be put in food, as long they were not crushed. Not sure about a G-tube, as beads of a certain size would clog the tube.

This is a cool HAL study which would support Tier 1 ADF labeling. What they did is to compare the bioavailabilty after oral intake of crushed DeterX oxy vs. crushed OxyContin vs. crushed oxyIR.

http://finance.yahoo.com/news/collegium-announces-publication-comparing-effect-121500225.html

Crushing Xtampza ER demonstrated no increase in Cmax, Tmax, or AUC and was bioequivalent to taking Xtampza ER intact capsules.

Crushing reformulated OxyContin demonstrated an increase in Cmax and a decrease in Tmax, and was bioequivalent to crushed IR oxycodone tablets.

They proved that chewing and swallowing DeterX oxy has no effect on bioavailabilty. User would get the same effect either way. But swallowing chewed/crushed OxyContin is bioequivalent to swallowing chewed/crushed non-ADF oxyIR. In other words, they proved that OxyContin's ADF is ineffective to prevent abuse by crushing or chewing then swallowing. Obviously, this is helpful to Elite, and I guarantee this data will be used in marketing ELI-201. (BTW, the effect of chewing/crushing and then swallowing ELI-201 will be naltrexone release and blocking of any opioid effect at all, unlike the DeterX, which gives the normal bioavailabilty. I suspect this would give ELI-201 an advantage over DeterX in head-to-head HAL studies for Tier 3 labeling, such as "Drug Liking" etc.)