FDA Approves IND for Elite Pharmaceuticals Abuse-Resistant Oxycodone

The FDA has approved Elite Pharmaceuticals' investigational new drug (IND) application for its abuse-resistant oxycodone product.

This product utilizes Elite's proprietary abuse-resistant technology (ART), incorporating an opioid antagonist designed to discourage and reduce abuse of narcotic analgesic medications by making the product more difficult to abuse when crushed, damaged or otherwise manipulated.

Under the IND, the company will conduct pharmacokinetic clinical studies using its ART formulation containing both the agonist and the antagonist in healthy human subjects. The study will evaluate the extent of naltrexone and oxycodone absorption from extended-release oxycodone HCl and 25 mg naltrexone HCl capsules administered unaltered versus crushed.