King, Pain Therapeutics submit abuse-resistant oxycodone NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
King Pharmaceuticals and Pain Therapeutics announce submission of an NDA for their abuse-resistant oral oxycodone formulation Remoxy June 10. The drug, designed to resist common methods of prescription drug misuse and abuse, is indicated for moderate to severe chronic pain. The filing included data from one pivotal trial conducted under a special protocol assessment in over 400 patients with osteoarthritis. There was a statistically significant mean decrease in pain intensity scores between treatment and placebo groups during the 12-week trial