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Abuse-Deterrent Opioids: US FDA Follows The ‘Route Of Abuse’ To Exclusivity

 
• By Sue Sutter

Inspirion’s MorphaBond win suggests agency’s thinking on three-year exclusivity for abuse-deterrent formulations has ‘evolved’ from a formulation-specific approach to one based on route of abuse.

The US FDA’s exclusivity determination for Inspirion Delivery Sciences LLC’s MorphaBond (morphine sulfate extended-release) suggests the agency currently favors a route-of-abuse-based approach to determining when opioid abuse-deterrent formulation labeling qualifies for three years of Waxman/Hatch marketing protection.

In deciding that MorphaBond’s intranasal, abuse-deterrence labeling qualifies for exclusivity, the agency expressly rejected a broader approach that would cover abuse deterrence generally, and a narrower approach that would attach...

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