| 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.