Saturday, November 22, 2014 12:49:20 PM
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Elite’s lead product is a twice-daily, two-bead formulation of oxycodone and naltrexone. The company intends to begin a small human study with its drug candidate later this year. “The more we look at the lab data though, the more we think that maybe we should go straight into a larger, bioequivalency study,” Mr. Treppel suggests. “But we haven’t made a final decision yet.”
The goal of the clinical program would be to show that Elite’s formulation is bioequivalent to Purdue Pharma’s twice-daily OxyContin, which has annual sales approaching $3-billion. “This would be a pivotal point for the company because once you complete a successful bioequivalency study, you are well on your way to having a commercial product,” he adds.
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