IZIPRY is built on Orexo’s powder-based drug delivery platform, AmorphOX, and is designed to reverse overdoses involving highly potent synthetic opioids such as fentanyl. Unlike liquid naloxone formulations, the dry powder is highly stable, less sensitive to temperature fluctuations, and can be used in freezing conditions. If approved, it would be the first nasal naloxone powder available in the US.

Bystanders and emergency medical services are increasingly giving multiple naloxone doses, and the US Drug Enforcement Administration (DEA) has warned that fentanyl combined with emerging synthetic opioids may need several doses to be effective. Because IZIPRY combines a high dose with rapid absorption and high bioavailability, it could reduce the need for repeat dosing.

The resubmission follows a Complete Response Letter from the FDA in July 2024. The agency’s acceptance confirms that the application contains the information it needs to assess whether the issues raised then have been addressed.

“Confirmation of the March 29, 2027 PDUFA target action date marks another important milestone toward potential FDA approval of IZIPRY,” says Nikolaj Sørensen, President and CEO of Orexo. “We look forward to the review process and to working with the agency to respond to any questions raised during the review, while seeking a commercialization partner for the US market.”