King, Pain Therapeutics submit abuse-resistant oxycodone NDA
This article was originally published in Pharmaceutical Approvals Monthly
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
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FDA accepts NDA for Pain Therapeutics' Remoxy and grants the pain medication priority review, firms announce Aug. 12. Remoxy, an abuse-resistant oral formulation of oxycodone, is being developed by King Pharmaceuticals and Pain Therapeutics under license from Durect (1Pharmaceutical Approvals Monthly June 2008, p. 40). Remoxy was designed using Durect's Oradur technology, which transforms short-acting capsule dosage forms into sustained release oral products that are less prone to abuse. The NDA was submitted June 10, giving the drug a December user fee date
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