Orexo develops improved pharmaceuticals addressing large medical needs. In the work to develop new drugs, well-known substances are combined with innovative proprietary drug delivery technologies, such as amorphOX®.
amorphOX® is a novel and scalable technology platform. It possesses unique properties that support highly differentiated pharmaceuticals and amorphOX® will form the backbone of the company’s future drugs.
research
research
Pipeline projects
OX124 - Opioid overdose rescue medication
| 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.
OX125 - Opioid overdose rescue medication
| Short facts | |
| API |
Naloxone |
| Technology |
Nasal |
| Indication |
Rescue medication, opioid overdose |
| Development phase |
Finalized phase 1 |
| Expected filing with FDA |
- |
| 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 powerful rescue medication for situations where very long-lasting effect is required, e.g., in remote areas, as response to long-acting opioids or for anti-terror stockpiling.
Differentiation
Results from the first exploratory human PK-study in healthy volunteers showed extensive and rapid absorption of nalmefene across all three OX125 formulations. As nalmefene has a longer half-life than naloxone, OX125 has the potential to be an effective response to the increased use of potent, long- acting synthetic opioids as well as protecting against renarcotization (second overdose) as the antagonist wears off. Novel, proprietary drug delivery technology with patent protection until 2039.
OX640 - Emergency treatment of allergic reactions
| Short facts | |
| API | Epinephrine (adrenaline) |
| Technology | amorphOX®, nasal powder technology |
| Indication | Emergency treatment of allergic reactions |
| Development phase | Positive data announced for phase 1 clinical study in 40 healthy volunteers assessing four investigational formulations of OX640 compared to a marketed epinephrine auto-injector. |
| Expected filing with FDA | - |
| In-house or partnership | Partnerships are under assessment for continued development and for commercialization. |
Unmet need
Today, allergic rescue products are needle-based auto injectors that administer adrenaline to reverse life-threatening reactions (anaphylaxis). Whether self-administered or with the help of others, applying needle injections correctly is often intimidating, with the potential loss of precious life-saving minutes. Current solutions are costly and devices must be replaced frequently because adrenaline rapidly degrades during storage.
The aim
With decades of no innovation, products like EpiPen dominates the market. Orexo will strive to bring to market a more fast-acting intranasal product, which is key in life-saving situations. Additionally, the single-dose nasal administration is easy to use and easy to teach others and easy to learn for caregivers.
Differentiation
Built on our amorphOX® platform, OX640’s dry-powder, single-use, intranasal delivery will provide rapid and extensive absorption with the potential of doubling the stability and shelf-life of current solutions. Moreover, OX640 is preservative-free with no sodium metabisulfite or other stability agents currently needed in today’s devices. These preservatives can in itself cause allergic reactions.
OX-MPI
| Short facts | |
| API | BI1029539 |
| Technology | - |
| Indication | Endometriosis |
| Development phase | Preparations ongoing to initiate a phase 2 study |
| Expected filing with FDA | - |
| In-house or partnership | In partnership with  |
3 Questions with Robert Rönn, SVP and Head of R&D
It has been an intensive and fruitful year where we have made important progress in several areas. Our commit- ment to help patients in the addiction field continues and our naloxone product for the treatment of opioid overdose, OX124, passed a significant milestone with the successful completion of a pivotal clinical study. In parallel, our focus on the development of innovative drug delivery solutions has resulted in amorphOX®, yet another important technology platform for Orexo. With amorphOX®, I see significant opportunities even beyond the addiction field and it has already enabled us to further progress our pharma pipeline with the addition of OX640, a nasal epinephrine product for the treatment of allergic reactions.
Our main priority is to complete the development of OX124 and file for approval in the US. We will also advance the development of OX640 and perform the first human clinical study. Furthermore, the development of OX125, our nalmefene product for opioid overdoses will continue.
My vision is to develop several new drugs based on the amorphOX® platform. In five years’ time, Orexo has initiated and led the development of multiple new pharma products approaching the market and we have a wide pipeline of development programs in various phases.
Within the business area HQ and Pipeline out-licensed pharmaceuticals are included, such as ZUBSOLV® for the EU market as well as Abstral® (break-through cancer pain) and Edluar® (insomnia). These drugs are developed, based on the company´s sublingual drug delivery platform.
Partnerships for out-licensed drugs
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EU Market |
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Worldwide ex the US and EU where patents have expired |
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Worldwide |
Product website not available |
