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.