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US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest

 
• By Sarah Karlin-Smith

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.

Steep grades and curves, road sign, dangerous road
Arbor faces a difficult road to advisory committee and FDA sign-off for its reformulated ADHD treatment • Source: Shutterstock

The US Food and Drug Administration’s advisory committee briefing documents for Arbor Pharmaceuticals, LLC’s attentive deficit hyperactivity disorder stimulant show the agency may be losing enthusiasm for abuse deterrent drug formulations following little real-world data on proven public health successes and some new risks with the category of medicines in the opioid space.

Arbor is seeking approval of AR19, immediate release amphetamine sulfate oral capsules for ADHD, under the 505(b)(2) pathway. The company reformulated the now generic Eveko to try and reduce abuse...

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