Alpharma abuse-deterrent opioid could see first half 2008 NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Alpharma's abuse-resistant extended-release morphine and naltrexone formulation ALO-01 is on track for NDA filing in the first half of 2008, based on results of a Phase III trial in 500 patients with chronic moderate to severe non-cancer pain that demonstrated that ALO-01 provided significant pain relief. For ALO-01, Alpharma combined extended-release morphine (it markets morphine ER as Kadian) with a "sequestered core" containing the opioid antagonist naltrexone. If taken as directed, the naltrexone remains sequestered; if the capsule is tampered with, the naltrexone is released and euphoria is reduced...