Orexo高剂量纳洛酮鼻用粉剂IZIPRY新药申请重新提交获FDA受理：目标审评日期定于2027年3月29日
瑞典制药公司 Orexo AB 10月29日宣布，美国食品药品监督管理局（FDA）已受理其高剂量纳洛酮鼻用粉剂 IZIPRY 重新提交的新药申请（NDA）进入审评，并确认六个月的审评期，《处方药申请者付费法案》（PDUFA）目标行动日期定于2027年3月29日。
IZIPRY 是一种用于阿片类药物过量的高剂量纳洛酮急救药，基于 Orexo 自有的 AmorphOX 粉末递送平台开发，针对的是芬太尼等高效合成阿片类药物导致的、往往需要更高剂量纳洛酮才能逆转的过量情形。其干粉鼻用剂型稳定性高、对温度波动不敏感，可在严寒条件下使用，与液体型纳洛酮产品形成区别；如获批准，它将成为美国市场上首款鼻用纳洛酮粉剂。
公司援引的真实世界证据显示，旁观者与急救人员使用多剂纳洛酮的情形日益增多；美国缉毒局（DEA）也曾提示，芬太尼与新出现的合成阿片类药物混合时，可能需要数剂纳洛酮才有效。IZIPRY 把高剂量与快速吸收、高生物利用度及耐温性结合，目标是减少重复给药、快速逆转危及生命的过量。
FDA 此次受理，确认重新提交的申请已包含评估此前问题所需的补充信息与文件。此前，FDA 曾在2024年7月就该申请发出完整回应函（CRL）。
Orexo 总裁兼首席执行官 Nikolaj Sørensen 表示，2027年3月29日这一 PDUFA 目标日期的确认，是 IZIPRY 迈向潜在 FDA 批准的又一个重要里程碑；公司期待审评进程，并将配合回应审评中提出的问题，同时为该产品在美国市场寻找商业化合作伙伴。
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.
来源：GSM·美国（原文链接）
图片来源：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.
