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KemPharm Seeks FDA Dispute Resolution Over Apadaz's Abuse Deterrence

 
• By Joseph Haas

Sponsor hopes to demonstrate that FDA's process for reviewing extended-release abuse-deterrent opioids may not be appropriate for an immediate-release product. Apadaz would be the first immediate-release opioid with an abuse-deterrent claim if approved.

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KemPharm Inc. is taking to FDA's dispute resolution process to resolve a complete response letter it received in June pertaining to Apadaz, its candidate for acute pain, arguing that current FDA standards for abuse-deterrent analgesic drugs are intended for extended-release formulations but perhaps not sufficient for immediate-release products.

In tandem with that Sept. 15 announcement, the Coralville, Iowa, firm also pushed back the expected timeline to launch for...

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US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
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More from Pathways & Standards

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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