Orexo AB has announces the resubmission of the new drug application (NDA) for Izipry (naloxone nasal powder) to the US Food and Drug Administration (FDA) was completed on 29 September 2026.
Izipry is a high-dose naloxone rescue medication for opioid overdose based on Orexo’s proprietary powder-based drug delivery platform AmorphOX. The product has been specifically designed to address the growing prevalence of overdoses requiring high doses of naloxone and involving highly potent synthetic opioids such as fentanyl1.Â
Real-world evidence shows increasing use of multiple naloxone administrations (MNA) by bystanders and EMS providers 2,3. The United States Drug Enforcement Agency (DEA) recently advised that fentanyl combined with emerging synthetic opioids might require several doses of naloxone to be effective4. Combining a high-dose strength with rapid absorption and high bioavailability, Izipry has the potential to reduce repeat dosing and rapidly reverse the life-threatening opioid overdose.
The resubmission includes additional information and documentation addressing the observations communicated by the FDA in its Complete Response Letter (CRL) issued in July 2024. Since receiving the CRL, Orexo has worked closely with manufacturing and development partners to fully address the identified deficiencies and further strengthen the application package.
Nikolaj Sørensen, president and CEO of Orexo AB, said, “The NDA resubmission for Izipry represents an important milestone for Orexo and reflects a tremendous effort by our team and external partners. We believe the application comprehensively addresses the points raised by the FDA and we look forward to continuing the review process. The opioid crisis continues to have devastating consequences across communities in the U.S., and we remain committed to bringing this innovative rescue medication to patients, caregivers and healthcare professionals in need of effective overdose treatment options.”
FDA is expected to notify the company regarding acceptance of the resubmission and communicate an updated review timeline in the coming weeks. Orexo will provide further updates as the regulatory process progresses.
Orexo continues preparations for the potential commercialization of Izipry in the United States. If approved, Izipry is expected to address the growing demand for more powerful rescue medications in a market increasingly affected by synthetic opioids such as fentanyl. The company is also evaluating opportunities to maximize the value of Izipry through commercial partnerships ensuring market access and broad patient reach.
Izipry is a high-dose naloxone nasal powder rescue medication for opioid overdose. The product is based on Orexo’s proprietary AmorphOX® technology, enabling rapid absorption, high bioavailability and improved stability compared with conventional formulations. Izipry is designed to address the increasing need for effective overdose rescue medications in the era of synthetic opioids. Izipry is under review by the FDA.
