The funding will support the development of OX390, an intranasal rescue medication for adulterated opioid overdoses.

The award is structured in five stages and is valued at up to USD 50.9 million that could be awarded if specific milestones and deliverables are achieved. It will contribute to the funding for Orexo to perform non-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory filing for a formulation of OX390 suitable for community use, the company states.

“We aim to develop a rapidly deployable intranasal rescue medication using our proprietary AmorphOX technology for the emergency treatment of respiratory depression associated with adulterated illicit opioids. There is a crucial need for new treatment options that can complement opioid antagonists for the increasing number of patients exposed to adulteration of illicitly manufactured opioids. We look forward to continuing our collective efforts to develop medical countermeasures as the American opioid epidemic continues to evolve and expose the public in the US to new lethal adulterations of opioids,” says Nikolaj Sørensen, President and CEO of Orexo AB.

The first stage of the contract provides approximately USD 8 million to support the completion of the agreed activities. Upon completion of the project and FDA approval of the product, Orexo will retain all commercial rights to OX390.

“OX390 (currently in pre-clinical phase) meets a need for a rescue drug on the US market that is effective for those who have overdosed on a mixture of opioids and other illicit substances. Here, neither naloxone nor nalmefene (antagonists) work as effectively. Although overdoses in the US are decreasing, this is becoming an increasingly common problem, which also makes it more challenging for emergency personnel and relatives in these emergency situations,” adds Sørensen. “New mixtures of dangerous substances are a challenge for American society and part of the ongoing opioid crisis. Seizures of mixtures of dangerous substances have occurred in 48 US states, and 12 of 38 states have reported detecting the mixtures in more than 10% of fatal overdoses. Among other things, the Centers for Disease Control have issued several health alerts about the clinical challenges of treating this new category of overdoses.”

The development of OX390 means that Orexo has the potential to broaden its portfolio of products that help combat the opioid crisis.