US FDA rejects Endo's harder-to-abuse Opana ER
This article was originally published in Scrip
Executive Summary
The US FDA rejected Endo Pharmaceuticals' application for what the company hoped to market as a harder-to-abuse formulation of its extended-release oxymorphone drug Opana ER. The company is seeking approval of the drug as a therapy to relieve moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.