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Elite Posts Positive Phase I Results for Painkiller


Posted on 2006-06-27 12:30:00



Elite Pharmaceuticals Inc. said Tuesday it will move to a mid-stage study of its pain treatment candidate after two early stage trials proved successful.

The drug candidate, an oxycodone called ELI-154, is a controlled release pain medication meant to keep the same level of the medication in the blood stream for a 24-hour period.

Elite compared the drug in the trial of 19 men with Oxycontin, made by Purdue Pharma LP.

The study showed that where Oxycontin has valley between two 12-hour doses, that gap was absent in the ELI-154 24-hour dose. This result came during the second Phase I clinical trial, with the first being conducted to determine proof of concept.

There is no once-daily oxycodone on the market the company said in a statement, touting the candidate as "abuse resistant." Oxycontin has made headlines over the last few years because of its addictive qualities and law enforcement efforts to stem abuse of the painkiller.

Elite said it hopes to meet with the Food and Drug Administration to discuss its development program for the Phase II clinical trial of the drug.