OX51 - prevention of acute episodes of pain

OX51 is a novel sublingual formulation comprising alfentanil. The project has been developed to meet the rapidly growing demand for effective pain relief during short surgical and diagnostic procedures, and ER/ ambulatory settings. A phase 2 study in patients undergoing prostate biopsy was successfully completed and supports the continuation of the development program. The commercial potential of OX51 is estimated to be substantial and Orexo aims to identify a partner for phase 3 clinical development and commercialization in select geographies.

New formulation technologies

OX382 - oral formulation

Many active ingredients face major challenges when administered by the oral route. For example, incomplete dissolution in the GI-tract, poor intestinal absorption and extensive metabolism may all limit bioavailability. Consequently, many drugs are not effective when administered orally. Orexo is currently developing a new formulation technology that can overcome these issues, enabling oral administration of drugs for which this route is not feasible today. The project is in the exploratory phase, and several active substances have been identified as promising candidates for this technology.

In Q2 2017 we obtained promising data with the first active substance from animal studies in rats and will proceed into clinical phase I trial within the next 6 to 9 months with the results expected first half of 2018.

2nd generation sublingual formulation technology

Orexo is currently developing its second-generation sublingual formulation technology. The aim is to perfect the sublingual delivery of drugs, thereby unlocking new active ingredients that are currently not possible to administer sublingually. The project is in the exploratory phase, and several active ingredients have been identified as promising candidates for this technology.