Northvale, New Jersey, Tuesday, February 18, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. Three different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.
The formulations tested utilize Elite's proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were evaluated based upon a naltrexone assay with a level of detection (LOD) of 4 pc/mL. The study results demonstrated that Elite's formulations were superior to an approved and marketed comparator product using a similar pharmacological approach. The comparison was based upon publicly available data from a similar fasted study in healthy volunteers and using a similar naltrexone assay with an LOD of 4 pc/mL. The primary metabolite of naltrexone, 6-Beta-natrexol, was also analyzed in the Elite study although no data from the comparator product was available for direct comparison.
Have you noticed NOT ONE trial or study has been unsuccessful. None have had to be repeated. The FDA will have1-2 ADT opiods on the fast track this year. eltp
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