Durect oxycodone drug Remoxy gets priority review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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