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US panel reviews abuse-deterrent opioids Remoxy and Embeda

This article was originally published in Scrip

Executive Summary

The US FDA's anaesthetic and drug safety advisory panels will meet jointly to discuss NDAs for two opioids with purported abuse-deterrent properties. On November 13th they will review Pain Therapeutics/King Pharmaceuticals' Remoxy XRT (oxycodone controlled-release) for moderate to severe pain when around-the-clock analgesia is needed for an extended period of time. On November 14th the panels will focus on Alpharma's Embeda (morphine sulphate extended-release plus sequestered naltrexone) for moderate to severe chronic pain. Claims that the two products' formulations deter tampering and abuse could meet with scepticism from the agency and its advisors. In May the panellists said Purdue Pharma's proposed reformulation of Oxycontin (oxycodone extended-release) was unlikely to reduce abuse or diversion and should not be marketed without further data. King is currently trying to acquire Alpharma, but the latter's board has opposed the move.

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