OX124 - Opioid overdose rescue drug

Short facts  
API

Naloxone

Technology

Powder technology, nasal delivery

Indication

Opioid overdose

Development phase

Published positive results from the pivotal trial, OX124-002. Commercial manufacturing established while mandatory stability study is ongoing and is expected to be finalized in H2 2022.

Expected filing with FDA

In H2 2022

Expected launch

US market in H2 2023

In-house or partnership

In-house

 

Unmet need
Available rescue medications have been developed for heroin overdoses, but most patients are dying from synthetic opioids like fentanyl today.

Our aim
Based on Orexo´s novel intranasal formulation technology, the aim is to develop a rescue medication that is faster and longer-acting, and thus effective in reversing overdoses caused by synthetic opioids.

Differentiation
Results from the exploratory pharmacokinetic study (PK-study) in healthy volunteers showed significantly better PK-profile, such as faster and longer-acting, when compared to the market leading product. Novel, proprietary drug delivery technology with patent protection until 2039.