Elite Pharmaceuticals Inc (ELTP)

[Couch]

The initial study successfully demonstrated the euphoria-blocking effect of ELI-216. This study was designed to determine the optimal ratio of oxycodone hydrochloride and opioid antagonist, naltrexone hydrochloride, to significantly block the euphoric effect of the opioid if the product is abused.

The study successfully demonstrated the euphoria-blocking effects of ELI-216. Without abuse deterrent technology, the subjects (n=17) dosed with crushed oxycodone hydrochloride 40 mg extended release capsules reported a high level of euphoria during the first three hours (average peak of 71 on the euphoria scale) and ELI-216 crushed (n=11) showed very low levels of euphoria (less than 10 on the scale). The study showed similar results with other levels of oxycodone hydrochloride. The study also helped determine the appropriate levels of naltrexone hydrochloride required to reduce or eliminate the euphoria experienced by subjects who might take crushed product to achieve a “high”.