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Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations

 
• By Sue Sutter

Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.

American Football Goal Posts
What the US FDA sees as new and emerging methods of manipulation to defeat abuse-deterrent formulations, Pain Therapeutics sees as moving the goalposts for regulatory approval.

The postmarketing safety problems seen with Endo Pharmaceuticals Inc.'s withdrawn long-acting opioid Opana ER have led to a new level of US FDA preapproval scrutiny of opioid formulations purported to be abuse deterrent.

The agency is increasingly weighing the downstream public health impacts when opioid formulations that are designed to deter abuse are used in ways that were not intended, and the agency is also taking a closer look at the

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