Orexo has completed the trial for its lead pharmaceutical pipeline asset, OX124, and the study met its primary endpoints with naloxone exposure within the targeted interval.

OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product, states the company.

A US launch will be initiated in H2 2023

Furthermore, OX124 was found to be well tolerated. Based on the outcome of the study, Orexo is expecting to file a New Drug Application with the US Food and Drug Administration (FDA) in H2 2022, when results from the ongoing, required stability study is available. Following FDA approval, a US launch will be initiated in H2 2023.

“The successful result from the pivotal trial for OX124 is a critical milestone for Orexo. I am looking forward to making this life-saving medication as widely available as possible so treatment is on hand when needed. Together with ZUBSOLV and our new digital therapy MODIA for opioid use disorder, Orexo will soon be the company offering the most comprehensive range of treatment options for patients suffering from opioid addiction in the US and continues to be at the forefront of fighting this devastating disease,” says Nikolaj Sørensen, President and CEO of Orexo.

The market has grown significantly during 2021

The market for naloxone rescue medication in the US is dominated by one player that commercializes the first FDA approved nasal naloxone rescue medication. With the rapid increase in overdoses in the US, the market has grown significantly during 2021 and the sales from the current market leader increased 50 percent versus the same quarter last year, describes Orexo. As a response to increased utilization of synthetic opioids and that other high-dose entrants are entering the market the expectations are that the high-dose alternatives will gain increasing market share. With Orexo’s established networks in the opioid use disorder (OUD) market and broad product offering for patients with OUD, Orexo has a strong foundation to reach the patients who need these products the most, the company states.

The commercial manufacturing of OX124 is established and the regulatory stability study is ongoing. Orexo will now continue to document the functionality of the nasal product, conduct a usability study (human factor study) and ensure OX124 meets the reliability requirements from the FDA, it states.

Photo of Nikolaj Sørensen: Jenny Öhman/Nordic Life Science