Orexo resubmits IZIPRY naloxone nasal powder NDA to FDA for opioid overdose treatment

Orexo said it completed its FDA resubmission of the IZIPRY (naloxone nasal powder) NDA on Sept. 29, 2026, addressing deficiencies cited in a July 2024 complete response letter. FDA acceptance decision and an updated review timeline are expected in coming weeks.