Orexo’s new drug effective against opioid overdoses

pharmafile | November 16, 2021 | News story | Manufacturing and Production  

Orexo announced it has successfully completed the trial for its lead pharmaceutical pipeline asset, OX124, designed to help patients in the fight against synthetic opioid overdoses. The drug showed a significantly faster and higher absorption of naloxone, in comparison to intramuscular dosing with the injection reference product.

The study met its primary endpoints with naloxone exposure within the targeted interval, and was found to be well tolerated. Orexo is expecting to file a New Drug Application with the FDA in H2 2022, once results from the ongoing, required stability study are available. OX124 fights overdoses caused by the most powerful opioids which are behind the majority of fatal overdoses in the US. It is a powerful high-dose naloxone rescue medication designed to reverse opioid overdoses, including those from highly potent synthetic opioids, including fentanyl.

Orexo developed a patented powder formulation technology to allow for rapid and efficient delivery of active ingredients through the intranasal route.

Nikolaj Sørensen, President and CEO of Orexo AB, stated: “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.”

The use of synthetic opioids is the leading cause of death in fatal overdoses in the US, a trend that has increased in the wake of the COVID-19 pandemic. For the twelve-month period approaching March 2021, the number of reported overdose deaths surpassed 96,000 for the first time in history, an increase of 30% in comparison with the previous year. Around 75% of these deaths were caused by opioids.

Ana Ovey

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