Izipry™

High-dose naloxone rescue medication for synthetic opioid overdose

Opioid overdose is a life-threatening condition marked by respiratory depression and loss of consciousness. Izipry™ is based on the AmorphOX® technology and is a high-dose naloxone rescue medication designed to reverse overdoses from potent synthetic opioids, including fentanyl and its analogues.

Substance

Powder-based naloxone

Development phase

FDA registration

Temperature stability1

≤0.1% after 24 months

Administration

Nasal powder

Leverage established manufacturing processes

Yes

Partnership

Seeking partnership for commercialization in the US

Differentiation and intellectual property

Izipry demonstrates:

  • Formulations have demonstrated significantly faster absorption and higher plasma concentrations of naloxone compared to intramuscular injection.
  • Formulations have demonstrated superior performance in cross-study comparisons with the current market leader, delivering higher peak plasma levels and total exposure, which are critical for preventing brain damage and saving lives.
  • Enhanced stability through the powder formulation, ensuring resilience from sub-zero to above room temperatures, without loss of efficacy. Izipry is protected by patents until 2039, securing long-term exclusivity.

Development reached FDA registration phase

The New Drug Application (NDA) for Izipry was resubmitted to the FDA during the third quarter of 2026. The submission included supportive stability and reliability data generated from studies of the final commercial product. Orexo continues preparations to support the review process while advancing ongoing partnering discussions. Orexo is seeking partnership for commercialization in the US and other markets.

Study testing

Naloxone formulations by AmorphOX compared with Narcan®

Findings: Studies demonstrate that nasal powders formulated with AmorphOX® achieve higher plasma concentrations of naloxone, provide more sustained effects, and are absorbed more rapidly compared to Narcan® liquid nasal spray.

  1. Chemical degradation after accelerated stability studies in 40°C/75% RH. Note: Narcan® is a registered trademarks of Emergent BioSolutions Inc.

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Orexo

Launched products

By applying its specialized drug delivery expertise to well-known active ingredients, Orexo has successfully advanced multiple candidates from development to global commercialization.

Partnership

Partner with us

We power partners´ proprietary projects with the AmorphOX® technology.