| Short facts | |
| API | Naloxone |
| Technology | Nasal |
| Indication | Rescue medication opioid overdose |
| Development phase | Finalized phase 1, will soon enter the final development stage - a pivotal bridging study |
| Expected filing with FDA | Q4 2021 or Q1 2022 |
| 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.