Elite Pharmaceuticals to start phase 2 trial for abuse-resistant drug product

By Elaine Rigoli

Tampa, Fla., Sept. 6 - Elite Pharmaceuticals, Inc. has received approval from an independent review board to begin a phase 2 clinical trial of its abuse-resistant drug product, ELI-216.

This product uses the specialty pharmaceutical company's patent-pending abuse resistant technology, based on a pharmacological intervention approach. The product uses an agonist-antagonist combination approach to deter opioid abuse.

ELI-216 is a combination of 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.

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.

The Northvale, N.J.-based company's phase 1 trial showed that there were no quantifiable levels of naltrexone hydrochloride in the bloodstream when ELI-216 was administered intact to healthy subjects, but was released into the bloodstream as intended when ELI-216 was crushed.

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