Orexo's IZIPRY Naloxone Nasal Powder NDA Resubmission Accepted by FDA: PDUFA Target Date Set for March 29, 2027
Orexo AB announced on October 29 that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for IZIPRY, its high-dose naloxone nasal powder, and confirmed a six-month review timeline, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 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 for overdoses that increasingly require high doses of naloxone, including those involving highly potent synthetic opioids such as fentanyl. Its dry powder nasal formulation is highly stable, has low sensitivity to temperature fluctuations and can be used in freezing temperatures, differentiating it from liquid naloxone alternatives; if approved, it would be the first nasal naloxone powder available in the United States.
Real-world evidence shows increasing use of multiple naloxone doses by bystanders and emergency medical services providers, and the U.S. Drug Enforcement Administration (DEA) has advised that fentanyl combined with emerging synthetic opioids may require several doses to be effective. By combining a high dose with rapid absorption, high bioavailability and temperature resilience, IZIPRY is intended to reduce repeat dosing and rapidly reverse life-threatening overdoses in warmer and colder climates alike.
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).
President and CEO Nikolaj Sørensen said confirmation of the March 29, 2027 PDUFA target action date marks another important milestone toward potential FDA approval of IZIPRY, and that the company looks forward to the review process and to working with the agency on any questions raised, while seeking a commercialization partner for the U.S. market.
Source: GSM · USA (original Chinese edition)
Photo: 图：盐酸纳洛酮预充注射剂包装实物（资料图，与纳洛酮急救药题材相关，非 IZIPRY 本品）。Intropin 摄，CC BY-SA 4.0，经 Wikimedia Commons。Photo: A naloxone hydrochloride prefilled syringe package (file photo, not IZIPRY itself). Intropin, CC BY-SA 4.0, via Wikimedia Commons.
