Alkermes' Vivitrol For Opioid Dependence Could Be Dealt Wild Card At Advisory Committee
This article was originally published in The Pink Sheet Daily
Expert panels have recently shown they may think differently from FDA on the subject of opioids..
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Prior training programs have been much smaller in scope, OND Director John Jenkins points out.
Alkermes' four-year-old Vivitrol has been struggling to get its head above water as a therapy for alcoholism. But fast-track status for a new opioid addiction indication and a slew of supportive studies at the American Psychiatric Association meeting offer the $900-a-month injectable a shot at recovery
FDA's advisory committees honed in on the inherent paradox in the regulation of abuse-resistant opioid painkillers - that it is impossible to fully prove an abuse-deterrent effect without approving a product and seeing how it works on the market - at the April 22 review of King/Acura's Acurox