Orexo AB has announced that the US Food and Drug Administration (FDA) has accepted for review the resubmitted new drug application (NDA) for Izipry (naloxone nasal powder). The FDA has set a prescription drug user fee Act (PDUFA) target action date of 29 March 2027.
Izipry is a high-dose naloxone rescue medication for opioid overdose, developed using Orexo’s proprietary AmorphOX powder-based drug delivery platform. It is designed to address the growing prevalence of overdoses requiring high doses of naloxone, including those involving highly potent synthetic opioids such as fentanyl1. Its dry powder nasal formulation is highly stable, has low sensitivity to temperature fluctuations, and can be used in freezing temperatures, differentiating it from other liquid naloxone alternatives.
Real-world evidence shows increasing use of multiple naloxone doses by bystanders and emergency medical services providers. The US Drug Enforcement Administration (DEA) has also advised that fentanyl combined with emerging synthetic opioids may require several naloxone doses to be effective4.
By combining a high dose with rapid absorption, high bioavailability, and temperature resilience, Izipry has the potential to reduce repeat dosing and rapidly reverse life-threatening opioid overdoses in warmer and colder climates.
The FDA’s acceptance confirms that the resubmission contains the additional information and documentation needed to review whether it addresses the observations in the agency’s July 2024 Complete Response Letter (CRL).
Nikolaj Sørensen, president and CEO of Orexo AB, said, “Confirmation of the March 29, 2027 PDUFA target action date marks another important milestone toward potential FDA approval of Izipry. Acceptance for review confirms that the application contains the information needed for the FDA to assess whether the issues previously raised have been adequately addressed. We look forward to the review process and work with the agency to respond to any questions raised during the review while seeking a commercialization partner for the U.S. market.”
Commercialization and partnership opportunities
Orexo continues to prepare for the potential US commercialization of Izipry, focusing on commercial partnerships to secure market access and broad patient reach. If approved, Izipry is expected to be the first nasal naloxone powder available in the United States and will address growing demand for high-dose rescue medications in a market increasingly affected by synthetic opioids such as fentanyl.
