Elite Pharmaceuticals Inc (ELTP)

[Couch]

The studies were conducted on sixteen healthy human volunteers. Test subjects were given a single dose of intact and crushed forms of OxyNal™ under fasted conditions. Oxycodone and naltrexone levels were measured in the subjects' blood. The following results were achieved:

Performance of Intact Capsules: This study was designed to evaluate the pharmacokinetics of OxyNal’s™ formulation when it was administered to the subjects in its unaltered form. The results showed that no quantifiable blood levels of naltrexone were released at a limit of quantification ("LOQ") of 7.5 pg/mL while the oxycodone showed a typical release profile for a 12-hour product, thus provides the desired effect of pain relief. This data is consistent with the premise of Elite's ART™, that essentially no naltrexone is released and absorbed when administered as intended.