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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...

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The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.