Elite's abuse-resisitant oxycodone gets IND

The USA's Elite Pharmaceuticals says that that the US Food and Drug Administration has approved an Investigational New Drug application for its abuse-resistant oxycodone product.

The agent harnesses the firm's proprietary abuse-resistant technology, incorporating an opioid antagonist designed to reduce abuse of narcotic analgesic medications by making the product more difficult to enjoy when crushed, damaged or otherwise manipulated.

Under the IND, the company will conduct pharmacokinetic clinical studies using its formulation containing both the agonist and the antagonist in healthy human volunteers. The study will evaluate the extent of naltrexone and oxycodone absorption from extended-release oxycodone and 25mg naltrexone capsules, administered unaltered versus crushed. The firm noted that its ART can be applied not only to the addressable oxycodone market worth $2.0 billion, but to many other opioids open to abuse.