Opioid Abuse-Deterrence: Immediate Release Formulation Is Chance For US FDA To Reassess Goal Posts

 
• By Michael Cipriano
  
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Inspirion's RoxyBond would be first immediate-release oxycodone with abuse deterrent properties, and it seems backed by solid data, but first it needs to make it past two advisory committee all too familiar with the law of unintended consequences.

The US FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committees will convene April 5 to assess what would be a milestone in efforts to reduce misuse of prescription opioids: Inspirion Delivery Sciences LLC's RoxyBond (oxycodone hydrochloride) could become the first immediate-release product approved with abuse-deterrent language in the labeling. The agency and its advisors, though, may be more than a little wary of the march of progress in this particular area, given that advances have seemed to move in lock step with unintended consequences.

There are currently nine FDA-approved opioids with abuse detterent language, all extended release. ER formulations are generally more attractive for...

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