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.”
No comments:
Post a Comment