ELITE TO INITIATE STUDY OF ABUSE-RESISTANT PAIN DRUG

Elite Pharmaceuticals has received approval from an independent review board (IRB) to initiate a Phase II clinical trial of its abuse-resistant pain drug, ELI-216.

This product uses the company's patent-pending abuse-resistant technology, based on a pharmacological intervention approach. The product utilizes an agonist-antagonist combination approach to deter opioid abuse. ELI-216 contains a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate-to-severe chronic pain, and an antagonist, naltrexone hydrochloride, formulated to deter abuse of the drug. Both of these compounds have been on the market for a number of years.

The study is designed to evaluate the euphoria-blocking effects of ELI-216 and to determine the appropriate levels of naltrexone hydrochloride required to reduce or eliminate the euphoria experienced by abusers of oxycodone hydrochloride.

A Phase I trial showed that there were no quantifiable levels of naltrexone hydrochloride in the bloodstream when ELI-216 was administered intact, but it was released into the bloodstream as intended when the drug was crushed.