Elite Pharmaceuticals (ELI) Provides Positive Clinical Update

February 15, 2007 8:59 AM EST

Elite Pharmaceuticals, Inc. (AMEX: ELI) has completed the first stage of its Phase II study for ELI-216 and is preparing to initiate the final stage. 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 next and final stage of this study will be a double blinded, cross-over pivotal study for submission to the FDA. The Company expects the final stage to begin by the end of this quarter.

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