Developed pharma products approved on markets worldwide

In our efforts to address unmet needs Orexo develops improved specialty pharma treatments by combining known pharmaceutical substances with its patented proprietary drug delivery technologies. The development process is characterized by lower risk and shorter time to market.

Since its inception, Orexo has developed three pharmaceutical products that are commercialized by Orexo in the US or worldwide through partners. These products have been developed with a focus on innovative solutions to address patient need, mostly within opioid addiction and pain. Today, Orexo is a well-established business with the financial resources and expertise to drive projects from concept to commercialization.

 

Pipeline of pharmaceuticals and development projects

Pharmaceuticals
Product/Project
Exploratory
Preclinical
Phase
1
2
3
Registration
Approved and/or Launched
US
EU
RoW
ZUBSOLV® Opioid Use Disorder
Abstral® Breakthrough Cancer Pain
Partner: Kyowa Kirin
Edluar® Insomnia
Partner: Mylan
OX124 Naloxone, Opioid overdose
OX125 Nalmefene, Opioid overdose
OX338 Ketorolac, Moderate to moderately severe pain
OX640 Adrenaline. Nasal adrenaline medication
OX-MPI BI1029539, microvascular Disease
Partner: Gesynta Pharma
Approved in Australia

Positive data from OX124 pivotal study

In the midst of November 2021 Orexo communicated positive data from the pivotal study for OX124, an opioid overdose rescue medication. The study met its primary endpoints with naloxone exposure within the targeted interval. Data from the study will be included in the NDA application that is planned to be submitted with the FDA in H2 2022.

Next generation technology

Orexo has successfully developed a drug delivery platform, amorphOX®, which is a novel and inventive powder-based technology, that is very rapidly dissolving and stable. As amorphOX® works with different APIs, dosage forms and administration routes it is a versatile platform with significant potential.