You were correct about Phase III passing
ELTP This is a huge opportunity to get in before filing and launch of their novel Abuse Deterrent Oxycodone.
Elite Pharmaceuticals Announces Positive Top-Line Results From a Pivotal Phase 3 Study for Abuse-Deterrent Opioid ELI-200 Meets Primary and Secondary Endpoints
NORTHVALE, N.J., Oct. 21, 2015 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: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."
About the Phase 3 ELI-200 Trial
The Phase 3 study evaluated safety and efficacy following dosing of ELI-200 for the treatment of moderate to severe pain following surgery. It was a multicenter, randomized, multiple-dose, double blind, placebo-controlled, and parallel group study. The clinical trial was conducted at five study sites in the United States which randomized 163 patients into the clinical study.
About Elite's Abuse Deterrent Technology
Elite's proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite's pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.
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