Elite Pharmaceuticals Inc (ELTP)

[abbey1212]

NORTHVALE, N.J., Oct. 21, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP) today announced positive top-line results from the Phase 3 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 U.S. Food and Drug Administration for abuse-deterrent ELI-200 by year-end.

"I am pleased with completing this important step in the commercialization of our first abuse-deterrent product, ELI-200," said Nasrat Hakim, President and Chief Executive Officer of Elite. "The next significant step will be the submission of the NDA for ELI-200 which I expect to occur by year-end.”