FDA accepts Orexo's IZIPRY opioid overdose treatment for review

• Orexo secured FDA acceptance for review of its resubmitted application for IZIPRY, a high-dose naloxone nasal powder for opioid overdose.
• The FDA confirmed a six-month review, setting a March 29, 2027, target action date.
• The review will assess whether the resubmission addresses issues raised in the FDA's July 2024 complete response letter.
• Developed using AmorphOX technology, IZIPRY offers rapid absorption, high bioavailability and stability in freezing temperatures.
• If cleared, IZIPRY would be the first nasal naloxone powder available in the United States; Orexo is seeking a commercialization partner.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Orexo AB published the original content used to generate this news brief on October 29, 2026, and is solely responsible for the information contained therein.