Successful Phase III trial for opioid abuse deterrent ELI 200 for treatment of moderate to severe pain- Elite Pharma

Elite Pharmaceuticals announced positive top-line results from the Phase III pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain. The pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial. Elite intends to submit a New Drug Application to the FDA for abuse-deterrent ELI-200 by year-end.