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news.Elite Pharmaceuticals has met primary endpoint in the phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, to treat moderate to severe pain.
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The trial showed statistical significance that the product provided pain relief after surgery in the treatment group using ELI-200 compared to the placebo group.
The company said secondary endpoint results were consistent with primary findings and included safety measures with no serious adverse events or deaths associated to ELI-200 reported during the trial.
The Phase I, open-label, randomized, single-dose, three-way crossover study compared the bioavailability of ELI-200 to the reference product under fed conditions in healthy volunteers.
The second study evaluated the potential withdrawal effects following administration of ELI-200 versus the reference product in methadone-maintained opioid-dependent subjects.
Elite Pharmaceuticals president and CEO Nasrat Hakim said: "I am pleased with completing this important step in the commercialization of our first abuse-deterrent product, ELI-200.
"The next significant step will be the submission of the NDA for ELI-200 which I expect to occur by year-end."
Elite has eight commercial products currently being sold, various additional approved products pending manufacturing site transfer and a further product under review pending approval by the FDA.
The company’s lead pipeline products include abuse-deterrent opioids using its patented technology, and a once-daily opioid.