US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest
Arbor Pharmaceuticals’ ADHD drug faces a challenging advisory committee after FDA questions whether even an effective abuse-deterrent stimulant formulation could produce a public health benefit. And the agency isn’t convinced that Arbor’s 505(b)(2) application for its immediate release amphetamine formulation has in fact demonstrated it would reduce abuse and misuse.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Label change is one option after US advisory committee review of Purdue’s postmarketing studies concludes reformulated OxyContin ‘meaningfully reduced abuse’ by non-oral routes, but finds there is not evidence to show such reduction via all routes or that ADF reduced risk of opioid overdose.
Abuse-deterrent formulations have been polarizing in the opioid space; now the US FDA wants feedback on developing the formulations for central nervous system stimulants, such as ADHD drugs, which could renew debate about the value of the formulations and how the agency should weigh public health considerations when deciding whether to approve an individual product.