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.
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
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.
