Orexo Submits Revised US FDA New Drug Application for Opioid Overdose Drug

MT Newswires · 2d ago
12:33 AM EDT, 09/30/2026 (MT Newswires) -- Orexo (ORX.ST) resubmitted a new drug application to the US Food and Drug Administration for Izipry, its high-dose naloxone nasal powder for the treatment of opioid overdose. The resubmission includes additional information and documentation to address deficiencies identified by the regulator in a complete response letter issued in July 2024, according to a Tuesday release. The Swedish drugmaker expects to receive a response from the FDA regarding an updated review timeline in the coming weeks. It is also simultaneously preparing for a potential US launch.