Elite Pharmaceuticals Announces Positive Top-Line Results

Elite Pharmaceuticals, Inc. recently 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 US FDA 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.”

The Phase III 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 US, which randomized 163 patients into the clinical study.

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 multiparticulate 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.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company, which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained- and controlled-release drug products, which have high barriers to entry. Elite owns generic and OTC products, which have been licensed to TAGI Pharma, Epic Pharma, and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer, and a product under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids, which utilize the company’s patented proprietary technology and a once-daily opioid. These products include sustained-release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong-based company for development of a branded product for the US market and its territories. Elite operates a GMP- and DEA-registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.